Anaemia
Conditions
Keywords
Anemia, Daprodustat, Blood pressure, ESA, CKD
Brief summary
This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD) participants with anemia associated with chronic kidney disease (CKD), designed to compare the effects of daprodustat to epoetin alfa on blood pressure (BP). Participants will be screened for eligibility within 7 and 30 days prior to erythropoesis-stimulating agent (ESA) washout. Following a 2-week ESA washout period, on Day 1 participants will be randomized 1:1 and stratified by prior ESA dose before they undergo Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the highest planned once-daily maintenance dose of daprodustat (24 milligrams \[mg\]) to the highest starting dose of epoetin alfa (100 units/kilogram \[U/kg\]). This will be followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either daprodustat or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance period, on Day 57 an Acute Challenge 2 will be repeated utilizing the same treatment dose administered in Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after completing treatment.
Interventions
DRUGDaprodustat
Daprodustat will be available as oral tablets at unit dose strength of 1, 2, 4, 6, 8 and 10 mg.
DRUGEpoetin alfa
Epoetin alfa will be administered according to local labelling and clinical practice guidelines to keep Hgb in the target range (10.0-11.0 g/dL)
Sponsors
ERT: Clinical Trial Technology Solutions
Q2 Solutions
Quintiles, Inc.
HemoCue
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* More than or equal to 40 years of age, at the time of signing the informed consent * Stable Hgb 8.5 to 11.5 grams per deciliter (g/dL) inclusive. * Dialysis frequency: On hemodialysis (HD, hemofiltration or hemodiafiltration) three-to five-times weekly for at least 4 weeks prior to screening. * A single pool Kt/Vurea \>=1.2 based on a historical value obtained within 3 months prior to screening in order to ensure the adequacy of dialysis. If Kt/Vurea is not available, then an average of the last 2 values of urea reduction ratio should be at least 65 percent (%). * Treated with an ESA (epoetins or their biosimilars, darbepoetin, or methoxy polyethylene glycol \[PEG\]-epoetin beta) for at least 4 weeks prior to screening. * Participants may be on stable (\<=50% change in overall dose and compliance of 80% of prescribed doses in the 4 weeks prior to and including the screening period) maintenance oral or intravenous (IV; \<=100 mg/week) iron supplementation. If participants are on oral or IV iron, then doses must be stable for the 4 weeks prior to Washout. * Weight: Mid-week weight change between dialysis treatments \<5% as assessed post-dialysis at the Screening and Washout visits. * On at least 1 antihypertensive medication (excluding diuretics) and on that same medication and the same dose for at least 1 week prior to Washout. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol. * Willing and able to wear ABPM device for at least 25 hours on two separate sessions.
Exclusion criteria
* Planned change from HD to peritoneal dialysis within the study time period, or on home dialysis. * Planned for kidney transplant within the 16 weeks following the Screening visit. * An epoetin alfa dose of \>=360 U/kg/week IV or \>=250 U/kg/week subcutaneous (SC), or darbepoetin dose of \>=1.8 micrograms (μg)/kg/week IV or SC, or methoxy PEG-epoetin beta dose of \>=2.2 μg/kg/week within the 8 weeks prior to screening through Week -4. * Planned or recorded administration of Mircera (methoxy PEG-epoetin beta) within the 4 weeks prior to the Washout. * Occurrence of myocardial infarction or acute coronary syndrome within 3 months prior to Washout. * Stroke or transient ischemic attack within 3 months prior to Washout. * Chronic Class 4 heart failure, as defined by the New York Heart Association functional classification system diagnosed prior to Washout. * QT interval corrected for heart rate using Bazett's formula (QTcB) \>500 milliseconds (msec), or QTcB \>530 msec in participants with Bundle Branch Block. There is no QTc exclusion for participants with a predominantly paced rhythm. * Resting post dialysis SBP \>160 millimeters of mercury (mmHg); or DBP \>100 mmHg at screening or uncontrolled hypertension as determined by the investigator. * Presence of atrial fibrillation. * Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosus, rheumatoid arthritis, celiac disease) diagnosed prior to Washout. * History of bone marrow aplasia or pure red cell aplasia. * Other causes of anemia including Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome. * Alanine transaminase (ALT) \>2 times upper limit of normal (ULN) (screening only) or Bilirubin \>1.5 times ULN (screening only) or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Major surgery (excluding vascular access surgery) within the 3 months prior to Washout or planned during the study. * Blood transfusion within the 8 weeks prior to Washout or an anticipated need for blood transfusion during the study. * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal bleeding within the 8 weeks prior to Washout. * Clinical evidence of acute infection or history of infection requiring IV antibiotic therapy within the 8 weeks prior to Washout. * History of malignancy within the two years prior to screening through Day 1 or currently receiving treatment for cancer, or has a known complex kidney cyst (e.g., Bosniak Category IIF, III or IV) \>=3 centimeters. * Participants with an upper arm diameter which cannot be measured by oscillometer/ sphygmomanometer cuff or for whom BP cannot be measured in the opposite arm of current vascular access. * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product. * Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from screening until Washout. * The participant has participated in a clinical trial and has received an experimental investigational product within the 30 days prior to Day 1 or within 5 half lives of the investigational product prior to screening, whichever is longer. * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study. * A female participant is pregnant (as confirmed by a positive serum human chorionic gonadotrophin test for females of reproductive potential only), participant is breastfeeding, or participant is of reproductive potential and does not agree to follow one of the pre-specified contraceptive options * Vitamin B12 at or below the lower limit of the reference range (may rescreen in a minimum of 8 weeks, following treatment). * Folate at \<2.0 nanograms/milliliter (ng/mL) (4.5 Nanomoles per Liter) (may rescreen in a minimum of 4 weeks, following treatment). * Ferritin at \<100 ng/mL * Transferrin saturation at \<20%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM after 8 weeks of Hgb maintenace therapy on Day 57. Analysis was based on analysis of covariance (ANCOVA) with terms for treatment, prior erythropoiesis-stimulating agent (ESA) dose (low/high), post-Hemodialysis dependent (HD)/pre-AC 1 SBP, difference between post-HD/pre-AC 2 SBP and post-HD/pre-AC 1 SBP and treatment by difference in post-HD SBP between AC 1 and 2 interaction. Least square (LS) mean of 6 hour average SBP post AC2 on Day 57 and its corresponding standard error has been presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | Up to 6 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR. LS mean of 6 hour average HR post AC1 on Day 1 and its corresponding standard error has been presented. |
| Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | Up to 24 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 1. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. |
| AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1 | Up to 24 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. |
| Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing after AC2 on Day 57. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 DBP and MAP, difference between post-HD/pre-AC2 DBP and MAP and post-HD/pre-AC1 DBP and MAP and treatment by difference in post-HD DBP and MAP between AC1 and 2 interaction. LS mean of 6 hour average DBP and MAP post AC2 on Day 57 and its corresponding standard error has been presented. |
| Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR, difference between post-HD/pre-AC2 HR and post-HD/pre-AC1 HR and treatment by difference in post-HD HR between AC1 and 2 interaction. LS mean of 6 hour average HR post AC2 on Day 57 and its corresponding standard error has been presented. |
| AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | Up to 24 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. |
| AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57 | Up to 24 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. |
| Change From Pre-dose in SBP, DBP and MAP at Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose | The change from pre-dose in SBP, DBP and MAP was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement. |
| Change From Pre-dose in HR at Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose | The change from pre-dose in HR was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement. |
| Plasma Concentrations of Daprodustat | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for the concentrations of daprodustat. |
| Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Up to 6 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 SBP, DBP and MAP. LS mean of 6 hour average SBP, DBP and MAP post AC1 on Day 1 and its corresponding standard error has been presented. |
| Plasma Concentrations of Metabolite GSK2506104 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2506104. |
| Plasma Concentrations of Metabolite GSK2487818 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2487818. |
| Plasma Concentrations of Metabolite GSK2506102 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK25206102. |
| Plasma Concentrations of Metabolite GSK2531398 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531398. |
| Plasma Concentrations of Metabolite GSK2531401 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531401. |
| Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. |
| Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. |
| Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. |
| Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. |
| Plasma Concentrations of Metabolite GSK2391220 | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2391220. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Hematology Parameter: Ery. MCV | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. |
| Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. |
| Change From Baseline Values for ECG Mean Heart Rate | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Number of Participants With Any Serious Adverse Events (SAEs) | Up to Week 10 | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. |
| Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. |
| Absolute Values for Temperature | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. |
| Absolute Values for Pulse Rate | Baseline (Day 1, predose) and at Day 1:3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. |
| Change From Baseline Values for Vital Signs: SBP and DBP | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Temperature | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Pulse Rate | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs) | Up to Week 8 | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Number of participants with treatment emergent common (\>=2% non-SAEs in each arm) non-SAEs has been presented. |
| Number of Participants Who Discontinued the Study Treatment | Up to Week 10 | Number of participants who discontinued the study treatment due to any reason are presented. The reasons for discontinuation included adverse events, protocol specified withdrawal criteria met, physician decision and withdrawal by participant. |
| Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and Indrt bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and indrt. bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment. |
| Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Hematology Parameter: Hematocrit | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
| Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Baseline (Day 1) and at Days 29, 57 and Week 10 | Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. |
Countries
United States
Participant flow
Recruitment details
This was a randomized, open label study that evaluated the effect of daprodustat on blood pressure in participants with anemia associated with chronic kidney disease on hemodialysis switched from a stable dose of an erythropoiesis-stimulating agent.
Pre-assignment details
A total of 105 participants were enrolled of which 88 were randomized to receive study treatment. 17 did not receive study treatment as they were withdrawn prior to randomization due to adverse events (2); protocol deviation (2); protocol specified withdrawal criteria (3); lost to follow-up (1); physician decision (2) and withdrawal by participant (7).
Participants by arm
| Arm | Count |
|---|---|
| Daprodustat Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | 45 |
| Recombinant Human Erythropoietin Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | 43 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Hgb Maintenance Phase (8 Weeks) | Adverse Event | 2 | 2 |
| Hgb Maintenance Phase (8 Weeks) | Physician Decision | 1 | 1 |
| Hgb Maintenance Phase (8 Weeks) | Protocol-specified withdrawal criterion | 7 | 4 |
| Hgb Maintenance Phase (8 Weeks) | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Daprodustat | Recombinant Human Erythropoietin | Total |
|---|---|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 11.06 | 58.7 Years STANDARD_DEVIATION 10.61 | 59.8 Years STANDARD_DEVIATION 10.84 |
| Race/Ethnicity, Customized Black or African American | 21 Participants | 23 Participants | 44 Participants |
| Race/Ethnicity, Customized White-Arabic/North African Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 23 Participants | 20 Participants | 43 Participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 43 |
| other Total, other adverse events | 10 / 45 | 4 / 43 |
| serious Total, serious adverse events | 10 / 45 | 5 / 43 |
Outcome results
Primary
Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57
The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM after 8 weeks of Hgb maintenace therapy on Day 57. Analysis was based on analysis of covariance (ANCOVA) with terms for treatment, prior erythropoiesis-stimulating agent (ESA) dose (low/high), post-Hemodialysis dependent (HD)/pre-AC 1 SBP, difference between post-HD/pre-AC 2 SBP and post-HD/pre-AC 1 SBP and treatment by difference in post-HD SBP between AC 1 and 2 interaction. Least square (LS) mean of 6 hour average SBP post AC2 on Day 57 and its corresponding standard error has been presented.
Time frame: Up to 6 hours post dose on Day 57
Population: Intent-to-Treat (ITT)-Population comprised of all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | 142.87 Millimeters of mercury (mmHg) | Standard Error 3.039 |
| Recombinant Human Erythropoietin | Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | 143.03 Millimeters of mercury (mmHg) | Standard Error 2.995 |
p-value: 0.969495% CI: [-8.8, 8.47]ANCOVA
Secondary
Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 57, n=31 | 199.85 Hour*nanograms per milliliter | Geometric Coefficient of Variation 44.33 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 57, n=31 | 756.39 Hour*nanograms per milliliter | Geometric Coefficient of Variation 50.29 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 1, n=42 | 204.02 Hour*nanograms per milliliter | Geometric Coefficient of Variation 59.48 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 1, n=42 | 767.95 Hour*nanograms per milliliter | Geometric Coefficient of Variation 125.63 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 57, n=28 | 616.12 Hour*nanograms per milliliter | Geometric Coefficient of Variation 168.05 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 1, n=42 | 483.12 Hour*nanograms per milliliter | Geometric Coefficient of Variation 60.42 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 57, n=31 | 516.59 Hour*nanograms per milliliter | Geometric Coefficient of Variation 61.78 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 1, n=41 | 177.39 Hour*nanograms per milliliter | Geometric Coefficient of Variation 66.83 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 57, n=28 | 171.09 Hour*nanograms per milliliter | Geometric Coefficient of Variation 93.41 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 1, n=42 | 166.89 Hour*nanograms per milliliter | Geometric Coefficient of Variation 52.93 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 1, n=42 | 662.23 Hour*nanograms per milliliter | Geometric Coefficient of Variation 54.48 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 57, n=31 | 212.04 Hour*nanograms per milliliter | Geometric Coefficient of Variation 66.63 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 1, n=42 | 334.86 Hour*nanograms per milliliter | Geometric Coefficient of Variation 93.49 |
| Daprodustat | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 57, n=31 | 430.10 Hour*nanograms per milliliter | Geometric Coefficient of Variation 73.53 |
Secondary
Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1
The initial effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 1. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented.
Time frame: Up to 24 hours post dose on Day 1
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | AUEC of SBP | 3337.91 mmHg*Hours | Standard Error 84.144 |
| Daprodustat | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | AUEC of DBP | 1763.11 mmHg*Hours | Standard Error 39.814 |
| Daprodustat | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | AUEC of MAP | 2324.69 mmHg*Hours | Standard Error 57.517 |
| Recombinant Human Erythropoietin | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | AUEC of SBP | 3351.33 mmHg*Hours | Standard Error 90.217 |
| Recombinant Human Erythropoietin | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | AUEC of DBP | 1834.82 mmHg*Hours | Standard Error 42.688 |
| Recombinant Human Erythropoietin | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | AUEC of MAP | 2378.93 mmHg*Hours | Standard Error 61.668 |
p-value: 0.914295% CI: [-261.75, 234.92]ANCOVA
p-value: 0.226695% CI: [-189.21, 45.8]ANCOVA
p-value: 0.524695% CI: [-223.99, 115.51]ANCOVA
Secondary
AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1
The initial effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented.
Time frame: Up to 24 hours post dose on Day 1
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1 | 1652.63 Beats per minute*Hours | Standard Error 35.152 |
| Recombinant Human Erythropoietin | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1 | 1727.03 Beats per minute*Hours | Standard Error 37.69 |
p-value: 0.156395% CI: [-178.15, 29.34]ANCOVA
Secondary
AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57
The effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented.
Time frame: Up to 24 hours post dose on Day 57
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57 | 1579.38 Beats per minute*Hours | Standard Error 40.886 |
| Recombinant Human Erythropoietin | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57 | 1677.06 Beats per minute*Hours | Standard Error 43.736 |
p-value: 0.111995% CI: [-219.05, 23.71]ANCOVA
Secondary
AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57
The effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented.
Time frame: Up to 24 hours post dose on Day 57
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | AUEC of SBP | 3288.43 mmHg*Hours | Standard Error 85.805 |
| Daprodustat | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | AUEC of DBP | 1736.11 mmHg*Hours | Standard Error 38.659 |
| Daprodustat | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | AUEC of MAP | 2299.42 mmHg*Hours | Standard Error 58.712 |
| Recombinant Human Erythropoietin | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | AUEC of SBP | 3433.40 mmHg*Hours | Standard Error 91.786 |
| Recombinant Human Erythropoietin | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | AUEC of DBP | 1853.60 mmHg*Hours | Standard Error 41.354 |
| Recombinant Human Erythropoietin | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | AUEC of MAP | 2431.36 mmHg*Hours | Standard Error 62.804 |
p-value: 0.257395% CI: [-399.71, 109.76]ANCOVA
p-value: 0.04595% CI: [-232.26, -2.72]ANCOVA
p-value: 0.134195% CI: [-306.24, 42.36]ANCOVA
Secondary
Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57
The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing after AC2 on Day 57. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 DBP and MAP, difference between post-HD/pre-AC2 DBP and MAP and post-HD/pre-AC1 DBP and MAP and treatment by difference in post-HD DBP and MAP between AC1 and 2 interaction. LS mean of 6 hour average DBP and MAP post AC2 on Day 57 and its corresponding standard error has been presented.
Time frame: Up to 6 hours post dose on Day 57
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | DBP | 75.58 mmHg | Standard Error 1.465 |
| Daprodustat | Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | MAP | 98.98 mmHg | Standard Error 2.208 |
| Recombinant Human Erythropoietin | Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | DBP | 77.64 mmHg | Standard Error 1.436 |
| Recombinant Human Erythropoietin | Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | MAP | 101.49 mmHg | Standard Error 2.169 |
p-value: 0.324795% CI: [-6.23, 2.1]ANCOVA
p-value: 0.423595% CI: [-8.76, 3.74]ANCOVA
Secondary
Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1
The initial effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR. LS mean of 6 hour average HR post AC1 on Day 1 and its corresponding standard error has been presented.
Time frame: Up to 6 hours post dose on Day 1
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | 70.77 Beats per minute | Standard Error 1.416 |
| Recombinant Human Erythropoietin | Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | 73.72 Beats per minute | Standard Error 1.507 |
p-value: 0.164895% CI: [-7.14, 1.24]ANCOVA
Secondary
Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57
The effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR, difference between post-HD/pre-AC2 HR and post-HD/pre-AC1 HR and treatment by difference in post-HD HR between AC1 and 2 interaction. LS mean of 6 hour average HR post AC2 on Day 57 and its corresponding standard error has been presented.
Time frame: Up to 6 hours post dose on Day 57
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57 | 70.49 Beats per minute | Standard Error 1.146 |
| Recombinant Human Erythropoietin | Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57 | 70.62 Beats per minute | Standard Error 1.125 |
p-value: 0.935395% CI: [-3.41, 3.14]ANCOVA
Secondary
Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1
The initial effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 SBP, DBP and MAP. LS mean of 6 hour average SBP, DBP and MAP post AC1 on Day 1 and its corresponding standard error has been presented.
Time frame: Up to 6 hours post dose on Day 1
Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | SBP | 141.36 mmHg | Standard Error 3.115 |
| Daprodustat | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | DBP | 75.97 mmHg | Standard Error 1.253 |
| Daprodustat | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | MAP | 99.18 mmHg | Standard Error 2.212 |
| Recombinant Human Erythropoietin | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | SBP | 142.68 mmHg | Standard Error 3.313 |
| Recombinant Human Erythropoietin | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | DBP | 77.92 mmHg | Standard Error 1.332 |
| Recombinant Human Erythropoietin | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | MAP | 101.58 mmHg | Standard Error 2.351 |
p-value: 0.774595% CI: [-10.46, 7.83]ANCOVA
p-value: 0.29195% CI: [-5.62, 1.71]ANCOVA
p-value: 0.461195% CI: [-8.88, 4.07]ANCOVA
Secondary
Change From Pre-dose in HR at Day 1
The change from pre-dose in HR was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose
Population: ITT-Population. Only those participants with data available at specified time points has been presented (represented as n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 1, n=34, 31 | -1.16 Beats per minute | Standard Deviation 9.283 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 12, n=35, 28 | 0.77 Beats per minute | Standard Deviation 12.386 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 6, n=35, 31 | 0.97 Beats per minute | Standard Deviation 14.763 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 13, n=34, 28 | -0.25 Beats per minute | Standard Deviation 12.895 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 3, n=35, 31 | 0.76 Beats per minute | Standard Deviation 15.92 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 14, n=34, 31 | -1.54 Beats per minute | Standard Deviation 13.148 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 7, n=34, 26 | 2.14 Beats per minute | Standard Deviation 13.62 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 15, n=32, 26 | -0.92 Beats per minute | Standard Deviation 13.406 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 23, n=31, 26 | -1.01 Beats per minute | Standard Deviation 12.697 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 16, n=34, 31 | -1.02 Beats per minute | Standard Deviation 14.018 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 8, n=33, 29 | 0.62 Beats per minute | Standard Deviation 13.326 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 17, n=32, 30 | -0.85 Beats per minute | Standard Deviation 14.631 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 4, n=35, 31 | 3.18 Beats per minute | Standard Deviation 12.717 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 18, n=32, 27 | 0.60 Beats per minute | Standard Deviation 15.553 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 9, n=33, 30 | 0.20 Beats per minute | Standard Deviation 14.533 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 19, n=34, 27 | -0.56 Beats per minute | Standard Deviation 14.407 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 2, n=35, 31 | -1.05 Beats per minute | Standard Deviation 17.259 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 20, n=33, 27 | -1.91 Beats per minute | Standard Deviation 13.956 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 10, n=31, 28 | 2.54 Beats per minute | Standard Deviation 13.575 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 21, n=30, 27 | -1.82 Beats per minute | Standard Deviation 13.841 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 5, n=35, 31 | 0.91 Beats per minute | Standard Deviation 13.782 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 22, n=29, 27 | 0.82 Beats per minute | Standard Deviation 11.686 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 11, n=33, 27 | 2.07 Beats per minute | Standard Deviation 14.247 |
| Daprodustat | Change From Pre-dose in HR at Day 1 | Hour 24, n=31, 27 | -0.89 Beats per minute | Standard Deviation 17.53 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 14, n=34, 31 | 0.25 Beats per minute | Standard Deviation 13.02 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 24, n=31, 27 | -0.96 Beats per minute | Standard Deviation 14.651 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 1, n=34, 31 | 0.13 Beats per minute | Standard Deviation 15.465 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 2, n=35, 31 | -2.06 Beats per minute | Standard Deviation 15.409 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 3, n=35, 31 | -0.16 Beats per minute | Standard Deviation 14.911 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 4, n=35, 31 | -1.13 Beats per minute | Standard Deviation 17.798 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 5, n=35, 31 | -0.66 Beats per minute | Standard Deviation 14.119 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 6, n=35, 31 | -1.66 Beats per minute | Standard Deviation 13.023 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 7, n=34, 26 | -1.01 Beats per minute | Standard Deviation 11.592 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 8, n=33, 29 | -1.11 Beats per minute | Standard Deviation 18.376 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 9, n=33, 30 | 0.67 Beats per minute | Standard Deviation 15.411 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 10, n=31, 28 | 1.60 Beats per minute | Standard Deviation 13.612 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 11, n=33, 27 | 1.57 Beats per minute | Standard Deviation 14.132 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 12, n=35, 28 | -2.01 Beats per minute | Standard Deviation 14.767 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 13, n=34, 28 | -2.45 Beats per minute | Standard Deviation 14.861 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 22, n=29, 27 | -2.61 Beats per minute | Standard Deviation 13.292 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 15, n=32, 26 | -3.06 Beats per minute | Standard Deviation 13.156 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 16, n=34, 31 | -2.87 Beats per minute | Standard Deviation 11.762 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 17, n=32, 30 | -4.34 Beats per minute | Standard Deviation 13.284 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 18, n=32, 27 | 0.98 Beats per minute | Standard Deviation 11.443 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 19, n=34, 27 | -2.65 Beats per minute | Standard Deviation 13.22 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 20, n=33, 27 | -4.77 Beats per minute | Standard Deviation 17.083 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 21, n=30, 27 | -3.00 Beats per minute | Standard Deviation 13.342 |
| Recombinant Human Erythropoietin | Change From Pre-dose in HR at Day 1 | Hour 23, n=31, 26 | 0.24 Beats per minute | Standard Deviation 13.148 |
Secondary
Change From Pre-dose in SBP, DBP and MAP at Day 1
The change from pre-dose in SBP, DBP and MAP was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose
Population: ITT-Population. Only those participants with data available at specified time points has been presented (represented as n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 12, n=35, 28 | -4.79 mmHg | Standard Deviation 14.561 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 18, n=32, 27 | -5.23 mmHg | Standard Deviation 25.993 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 13, n=34, 28 | -2.15 mmHg | Standard Deviation 15.185 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 4, n=35, 31 | -1.68 mmHg | Standard Deviation 26 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 14, n=34, 31 | -3.99 mmHg | Standard Deviation 14.153 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 19, n=34, 27 | -3.01 mmHg | Standard Deviation 24.23 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 15, n=32, 26 | -0.54 mmHg | Standard Deviation 19.203 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 9, n=33, 30 | -5.81 mmHg | Standard Deviation 30.725 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 16, n=34, 31 | -3.56 mmHg | Standard Deviation 15.615 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 20, n=33, 27 | -13.27 mmHg | Standard Deviation 24.138 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 17, n=32, 30 | -3.65 mmHg | Standard Deviation 14.949 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 10, n=31, 28 | -5.70 mmHg | Standard Deviation 28.018 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 18, n=32, 27 | -2.08 mmHg | Standard Deviation 17.015 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 21, n=30, 27 | -8.32 mmHg | Standard Deviation 26.003 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 19, n=34, 27 | -0.36 mmHg | Standard Deviation 19.65 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 2, n=35, 31 | -4.99 mmHg | Standard Deviation 28.17 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 20, n=33, 27 | -2.96 mmHg | Standard Deviation 15.579 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 22, n=29, 27 | -3.93 mmHg | Standard Deviation 26.106 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 21, n=30, 27 | -2.54 mmHg | Standard Deviation 15.246 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 11, n=33, 27 | -7.00 mmHg | Standard Deviation 27.529 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 22, n=29, 27 | -0.25 mmHg | Standard Deviation 15.037 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 23, n=31, 26 | 2.73 mmHg | Standard Deviation 28.343 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 23, n=31, 26 | 4.05 mmHg | Standard Deviation 19.055 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 5, n=35, 31 | -1.86 mmHg | Standard Deviation 29.171 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 1, n=34, 31 | -1.87 mmHg | Standard Deviation 15.252 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 24, n=31, 27 | 2.63 mmHg | Standard Deviation 29.379 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 2, n=35, 31 | -4.79 mmHg | Standard Deviation 24.742 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 12, n=35, 28 | -6.05 mmHg | Standard Deviation 29.932 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 3, n=35, 31 | -5.13 mmHg | Standard Deviation 22.342 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 1, n=34, 31 | 0.01 mmHg | Standard Deviation 9.317 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 4, n=35, 31 | -4.78 mmHg | Standard Deviation 23.64 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 1, n=34, 31 | 1.00 mmHg | Standard Deviation 17.178 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 5, n=35, 31 | -3.48 mmHg | Standard Deviation 26.458 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 2, n=35, 31 | -0.82 mmHg | Standard Deviation 15.399 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 6, n=35, 31 | -1.27 mmHg | Standard Deviation 25.359 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 13, n=34, 28 | -2.49 mmHg | Standard Deviation 25.319 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 7, n=34, 26 | 0.45 mmHg | Standard Deviation 28.445 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 3, n=35, 31 | -1.30 mmHg | Standard Deviation 14.66 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 8, n=33, 29 | 0.08 mmHg | Standard Deviation 27.487 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 6, n=35, 31 | 0.29 mmHg | Standard Deviation 31.903 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 9, n=33, 30 | -7.02 mmHg | Standard Deviation 24.498 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 4, n=35, 31 | -1.06 mmHg | Standard Deviation 14.552 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 10, n=31, 28 | -8.18 mmHg | Standard Deviation 24.057 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 14, n=34, 31 | -5.30 mmHg | Standard Deviation 30.03 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 11, n=33, 27 | -8.74 mmHg | Standard Deviation 25.719 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 5, n=35, 31 | -0.69 mmHg | Standard Deviation 16.618 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 12, n=35, 28 | -6.49 mmHg | Standard Deviation 26.669 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 3, n=35, 31 | -5.85 mmHg | Standard Deviation 29.636 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 13, n=34, 28 | -5.72 mmHg | Standard Deviation 23.609 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 6, n=35, 31 | -0.06 mmHg | Standard Deviation 14.799 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 14, n=34, 31 | -6.99 mmHg | Standard Deviation 25.71 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 15, n=32, 26 | -1.47 mmHg | Standard Deviation 33.573 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 15, n=32, 26 | -4.06 mmHg | Standard Deviation 27.693 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 7, n=34, 26 | -0.12 mmHg | Standard Deviation 16.324 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 16, n=34, 31 | -4.79 mmHg | Standard Deviation 26.805 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 7, n=34, 26 | 2.30 mmHg | Standard Deviation 33.896 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 17, n=32, 30 | -5.10 mmHg | Standard Deviation 25.873 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 8, n=33, 29 | 1.35 mmHg | Standard Deviation 15.9 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 18, n=32, 27 | -6.98 mmHg | Standard Deviation 24.79 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 16, n=34, 31 | -4.40 mmHg | Standard Deviation 30.99 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 19, n=34, 27 | -4.44 mmHg | Standard Deviation 26.186 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 9, n=33, 30 | -2.14 mmHg | Standard Deviation 15.188 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 20, n=33, 27 | -9.47 mmHg | Standard Deviation 23.186 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 24, n=31, 27 | 4.48 mmHg | Standard Deviation 18.097 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 21, n=30, 27 | -7.39 mmHg | Standard Deviation 22.611 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 10, n=31, 28 | -3.52 mmHg | Standard Deviation 14.246 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 22, n=29, 27 | -2.77 mmHg | Standard Deviation 21.938 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 17, n=32, 30 | -5.05 mmHg | Standard Deviation 29.795 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 23, n=31, 26 | 0.88 mmHg | Standard Deviation 27.381 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 11, n=33, 27 | -4.88 mmHg | Standard Deviation 14.691 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 24, n=31, 27 | 2.02 mmHg | Standard Deviation 26.253 |
| Daprodustat | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 8, n=33, 29 | 0.43 mmHg | Standard Deviation 31.418 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 24, n=31, 27 | 2.20 mmHg | Standard Deviation 19.276 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 9, n=33, 30 | 0.25 mmHg | Standard Deviation 26.294 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 1, n=34, 31 | 5.27 mmHg | Standard Deviation 20.471 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 2, n=35, 31 | 4.72 mmHg | Standard Deviation 22.651 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 3, n=35, 31 | 5.09 mmHg | Standard Deviation 21.163 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 4, n=35, 31 | 0.93 mmHg | Standard Deviation 23.962 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 5, n=35, 31 | -2.10 mmHg | Standard Deviation 23.849 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 6, n=35, 31 | -2.54 mmHg | Standard Deviation 28.908 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 7, n=34, 26 | 0.63 mmHg | Standard Deviation 19.016 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 8, n=33, 29 | 3.83 mmHg | Standard Deviation 20.723 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 10, n=31, 28 | 1.48 mmHg | Standard Deviation 25.952 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 11, n=33, 27 | 1.96 mmHg | Standard Deviation 24.421 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 12, n=35, 28 | -1.67 mmHg | Standard Deviation 19.38 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 13, n=34, 28 | -1.37 mmHg | Standard Deviation 25.596 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 14, n=34, 31 | 4.57 mmHg | Standard Deviation 29.767 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 15, n=32, 26 | -0.13 mmHg | Standard Deviation 24.287 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 16, n=34, 31 | 8.59 mmHg | Standard Deviation 24.729 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 17, n=32, 30 | 1.76 mmHg | Standard Deviation 23.896 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 18, n=32, 27 | 5.48 mmHg | Standard Deviation 23.33 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 19, n=34, 27 | 1.52 mmHg | Standard Deviation 21.072 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 20, n=33, 27 | 6.89 mmHg | Standard Deviation 16.834 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 21, n=30, 27 | 1.72 mmHg | Standard Deviation 26.777 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 22, n=29, 27 | 3.50 mmHg | Standard Deviation 24.428 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 23, n=31, 26 | 8.72 mmHg | Standard Deviation 24.868 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | SBP, Hour 24, n=31, 27 | 5.02 mmHg | Standard Deviation 26.601 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 1, n=34, 31 | 0.99 mmHg | Standard Deviation 13.11 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 2, n=35, 31 | 1.97 mmHg | Standard Deviation 11.986 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 3, n=35, 31 | 0.88 mmHg | Standard Deviation 11.858 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 4, n=35, 31 | -1.17 mmHg | Standard Deviation 13.621 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 5, n=35, 31 | -1.49 mmHg | Standard Deviation 11.684 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 6, n=35, 31 | -1.49 mmHg | Standard Deviation 14.457 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 7, n=34, 26 | -1.27 mmHg | Standard Deviation 15.272 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 8, n=33, 29 | 1.79 mmHg | Standard Deviation 15.178 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 9, n=33, 30 | -0.68 mmHg | Standard Deviation 11.874 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 10, n=31, 28 | -0.82 mmHg | Standard Deviation 12.802 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 11, n=33, 27 | -2.45 mmHg | Standard Deviation 10.987 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 12, n=35, 28 | -3.95 mmHg | Standard Deviation 10.718 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 13, n=34, 28 | -2.65 mmHg | Standard Deviation 12.841 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 14, n=34, 31 | -1.00 mmHg | Standard Deviation 14.759 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 15, n=32, 26 | -4.12 mmHg | Standard Deviation 13.905 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 16, n=34, 31 | 1.15 mmHg | Standard Deviation 14.186 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 17, n=32, 30 | -2.98 mmHg | Standard Deviation 13.732 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 18, n=32, 27 | 0.30 mmHg | Standard Deviation 14.219 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 19, n=34, 27 | -0.43 mmHg | Standard Deviation 14.965 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 20, n=33, 27 | 0.40 mmHg | Standard Deviation 14.501 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 21, n=30, 27 | 1.90 mmHg | Standard Deviation 15.507 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 22, n=29, 27 | -1.96 mmHg | Standard Deviation 12.058 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 24, n=31, 27 | 2.16 mmHg | Standard Deviation 15.124 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 1, n=34, 31 | 2.83 mmHg | Standard Deviation 19.439 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 2, n=35, 31 | 4.20 mmHg | Standard Deviation 17.89 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 3, n=35, 31 | 3.46 mmHg | Standard Deviation 14.94 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 4, n=35, 31 | -1.05 mmHg | Standard Deviation 17.552 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 5, n=35, 31 | -1.18 mmHg | Standard Deviation 16.235 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 6, n=35, 31 | -2.17 mmHg | Standard Deviation 19.573 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 7, n=34, 26 | 0.87 mmHg | Standard Deviation 18.659 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 8, n=33, 29 | 2.20 mmHg | Standard Deviation 17.002 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 9, n=33, 30 | 0.61 mmHg | Standard Deviation 17.072 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 10, n=31, 28 | 0.76 mmHg | Standard Deviation 18.604 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 11, n=33, 27 | -3.60 mmHg | Standard Deviation 19.022 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 12, n=35, 28 | -6.15 mmHg | Standard Deviation 16.336 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 13, n=34, 28 | -3.32 mmHg | Standard Deviation 17.66 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 14, n=34, 31 | -0.75 mmHg | Standard Deviation 17.024 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 15, n=32, 26 | -5.10 mmHg | Standard Deviation 19.458 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 16, n=34, 31 | 3.84 mmHg | Standard Deviation 22.886 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 17, n=32, 30 | -2.09 mmHg | Standard Deviation 19.856 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 18, n=32, 27 | 1.52 mmHg | Standard Deviation 18.745 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 19, n=34, 27 | -1.02 mmHg | Standard Deviation 17.275 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 20, n=33, 27 | 4.23 mmHg | Standard Deviation 16.311 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 21, n=30, 27 | 3.87 mmHg | Standard Deviation 20.86 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 22, n=29, 27 | 0.75 mmHg | Standard Deviation 16.888 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | MAP, Hour 23, n=31, 26 | 4.10 mmHg | Standard Deviation 18.818 |
| Recombinant Human Erythropoietin | Change From Pre-dose in SBP, DBP and MAP at Day 1 | DBP, Hour 23, n=31, 26 | -0.44 mmHg | Standard Deviation 13.218 |
Secondary
Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 1, n=44 | 218.841 Nanograms per milliliter | Geometric Coefficient of Variation 187.869 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 57, n=32 | 163.795 Nanograms per milliliter | Geometric Coefficient of Variation 330.249 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 1, n=44 | 39.506 Nanograms per milliliter | Geometric Coefficient of Variation 66.816 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 57, n=32 | 44.703 Nanograms per milliliter | Geometric Coefficient of Variation 57.029 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 1, n=44 | 26.678 Nanograms per milliliter | Geometric Coefficient of Variation 79.992 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 57, n=32 | 24.846 Nanograms per milliliter | Geometric Coefficient of Variation 117.57 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 1, n=44 | 9.933 Nanograms per milliliter | Geometric Coefficient of Variation 62.188 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 57, n=32 | 12.114 Nanograms per milliliter | Geometric Coefficient of Variation 46.563 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 1, n=44 | 43.169 Nanograms per milliliter | Geometric Coefficient of Variation 61.558 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 57, n=32 | 51.643 Nanograms per milliliter | Geometric Coefficient of Variation 48.087 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 1, n=44 | 18.454 Nanograms per milliliter | Geometric Coefficient of Variation 67.277 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 57, n=32 | 20.362 Nanograms per milliliter | Geometric Coefficient of Variation 67.04 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 1, n=44 | 18.335 Nanograms per milliliter | Geometric Coefficient of Variation 96.906 |
| Daprodustat | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 57, n=32 | 23.337 Nanograms per milliliter | Geometric Coefficient of Variation 75.801 |
Secondary
Plasma Concentrations of Daprodustat
Blood samples were collected at indicated time points for the concentrations of daprodustat.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population comprised of all participants in the Safety population who had at least 1 non-missing pharmacokinetic assessment. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, Predose, n=45 | 0.000 Nanograms per milliliter | Standard Deviation 0 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 2 hours, n=30 | 245.277 Nanograms per milliliter | Standard Deviation 251.2676 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 3 hours, n=31 | 142.366 Nanograms per milliliter | Standard Deviation 154.9041 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 0.5 hours, n=43 | 197.118 Nanograms per milliliter | Standard Deviation 329.0251 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 1 hour, n=43 | 265.828 Nanograms per milliliter | Standard Deviation 340.769 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 2 hours, n=43 | 156.103 Nanograms per milliliter | Standard Deviation 150.4148 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 3 hours, n=43 | 114.485 Nanograms per milliliter | Standard Deviation 139.8114 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 4 hours, n=44 | 105.375 Nanograms per milliliter | Standard Deviation 150.0982 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 6 hours, n=44 | 71.995 Nanograms per milliliter | Standard Deviation 104.2462 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 8 hours, n=43 | 50.069 Nanograms per milliliter | Standard Deviation 91.2574 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 12 hours, n=41 | 14.165 Nanograms per milliliter | Standard Deviation 30.2719 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 16 hours, n=43 | 5.350 Nanograms per milliliter | Standard Deviation 11.0233 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 1, 24 hours, n=43 | 2.899 Nanograms per milliliter | Standard Deviation 10.8052 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, Predose, n=31 | 8.657 Nanograms per milliliter | Standard Deviation 21.3825 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 0.5 hours, n=31 | 175.616 Nanograms per milliliter | Standard Deviation 257.3578 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 1 hour, n=31 | 260.817 Nanograms per milliliter | Standard Deviation 307.2242 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 4 hours, n=32 | 82.696 Nanograms per milliliter | Standard Deviation 104.8654 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 6 hours, n=31 | 43.751 Nanograms per milliliter | Standard Deviation 55.8532 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 8 hours, n=31 | 16.484 Nanograms per milliliter | Standard Deviation 27.2733 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 12 hours, n=30 | 8.661 Nanograms per milliliter | Standard Deviation 16.8915 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 16 hours, n=30 | 7.279 Nanograms per milliliter | Standard Deviation 21.2784 |
| Daprodustat | Plasma Concentrations of Daprodustat | Day 57, 24 hours, n=31 | 1.371 Nanograms per milliliter | Standard Deviation 2.0177 |
Secondary
Plasma Concentrations of Metabolite GSK2391220
Blood samples were collected at indicated time points for the concentrations of metabolite GSK2391220.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 0.5 hours, n=43 | 9.847 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 1 hour, n=43 | 14.361 Nanograms per milliliter | Standard Deviation 21.6405 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 2 hours, n=43 | 30.036 Nanograms per milliliter | Standard Deviation 29.6152 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 3 hours, n=44 | 32.359 Nanograms per milliliter | Standard Deviation 28.6734 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, Predose, n=45 | 0.000 Nanograms per milliliter | Standard Deviation 0 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 4 hours, n=43 | 32.892 Nanograms per milliliter | Standard Deviation 27.2772 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 6 hours, n=43 | 33.105 Nanograms per milliliter | Standard Deviation 20.9136 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 8 hours, n=42 | 32.267 Nanograms per milliliter | Standard Deviation 16.3824 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 12 hours, n=40 | 23.921 Nanograms per milliliter | Standard Deviation 15.1007 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 16 hours, n=42 | 19.771 Nanograms per milliliter | Standard Deviation 13.5013 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 1, 24 hours, n=42 | 12.693 Nanograms per milliliter | Standard Deviation 10.1135 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, Predose, n=31 | 3.019 Nanograms per milliliter | Standard Deviation 4.2327 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 0.5 hours, n=31 | 10.043 Nanograms per milliliter | Standard Deviation 12.5832 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 1 hour, n=31 | 12.410 Nanograms per milliliter | Standard Deviation 13.3576 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 2 hours, n=30 | 23.433 Nanograms per milliliter | Standard Deviation 21.4154 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 3 hours, n=31 | 32.861 Nanograms per milliliter | Standard Deviation 26.3829 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 4 hours, n=32 | 38.443 Nanograms per milliliter | Standard Deviation 27.9354 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 6 hours, n=31 | 41.432 Nanograms per milliliter | Standard Deviation 24.2976 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 8 hours, n=31 | 33.689 Nanograms per milliliter | Standard Deviation 20.3669 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 12 hours, n=31 | 25.771 Nanograms per milliliter | Standard Deviation 17.8554 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 16 hours, n=31 | 21.481 Nanograms per milliliter | Standard Deviation 15.6404 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2391220 | Day 57, 24 hours, n=32 | 14.836 Nanograms per milliliter | Standard Deviation 11.2824 |
Secondary
Plasma Concentrations of Metabolite GSK2487818
Blood samples were collected at indicated time points for the concentrations of metabolite GSK2487818.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, Predose, n=45 | 0.000 Nanograms per milliliter | Standard Deviation 0 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 0.5 hours, n=43 | 8.624 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 1 hour, n=43 | 13.181 Nanograms per milliliter | Standard Deviation 19.228 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 2 hours, n=43 | 25.204 Nanograms per milliliter | Standard Deviation 24.8233 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 3 hours, n=44 | 23.632 Nanograms per milliliter | Standard Deviation 21.0661 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 4 hours, n=43 | 20.726 Nanograms per milliliter | Standard Deviation 17.9713 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 6 hours, n=43 | 15.509 Nanograms per milliliter | Standard Deviation 10.4545 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 8 hours, n=42 | 11.654 Nanograms per milliliter | Standard Deviation 9.1747 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 12 hours, n=39 | 5.673 Nanograms per milliliter | Standard Deviation 6.467 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 16 hours, n=43 | 3.298 Nanograms per milliliter | Standard Deviation 4.6779 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 1, 24 hours, n=43 | 1.379 Nanograms per milliliter | Standard Deviation 2.1969 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, Predose, n=31 | 1.503 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 0.5 hours, n=31 | 7.760 Nanograms per milliliter | Standard Deviation 12.2768 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 1 hour, n=31 | 10.507 Nanograms per milliliter | Standard Deviation 13.6474 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 2 hours, n=30 | 20.254 Nanograms per milliliter | Standard Deviation 20.1125 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 3 hours, n=30 | 25.092 Nanograms per milliliter | Standard Deviation 20.7688 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 4 hours, n=32 | 24.865 Nanograms per milliliter | Standard Deviation 18.7941 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 6 hours, n=31 | 21.749 Nanograms per milliliter | Standard Deviation 16.6572 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 8 hours, n=31 | 11.419 Nanograms per milliliter | Standard Deviation 11.2821 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 12 hours, n=31 | 5.537 Nanograms per milliliter | Standard Deviation 9.116 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 16 hours, n=30 | 3.613 Nanograms per milliliter | Standard Deviation 6.4974 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2487818 | Day 57, 24 hours, n=31 | 1.693 Nanograms per milliliter | Standard Deviation 2.9455 |
Secondary
Plasma Concentrations of Metabolite GSK2506102
Blood samples were collected at indicated time points for the concentrations of metabolite GSK25206102.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 2 hours, n=30 | 5.082 Nanograms per milliliter | Standard Deviation 4.1937 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 3 hours, n=31 | 7.688 Nanograms per milliliter | Standard Deviation 5.7677 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 4 hours, n=32 | 9.474 Nanograms per milliliter | Standard Deviation 6.3929 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 6 hours, n=30 | 11.507 Nanograms per milliliter | Standard Deviation 5.36 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 8 hours, n=31 | 10.945 Nanograms per milliliter | Standard Deviation 4.9425 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 12 hours, n=31 | 10.286 Nanograms per milliliter | Standard Deviation 5.1703 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 16 hours, n=31 | 9.735 Nanograms per milliliter | Standard Deviation 5.1306 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 24 hours, n=32 | 8.449 Nanograms per milliliter | Standard Deviation 3.7371 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, Predose, n=45 | 0.000 Nanograms per milliliter | Standard Deviation 0 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 0.5 hours, n=43 | 1.862 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 1 hour, n=44 | 2.575 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 2 hours, n=43 | 5.999 Nanograms per milliliter | Standard Deviation 5.9281 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 3 hours, n=44 | 7.047 Nanograms per milliliter | Standard Deviation 6.3772 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 4 hours, n=43 | 7.554 Nanograms per milliliter | Standard Deviation 6.0767 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 6 hours, n=43 | 8.564 Nanograms per milliliter | Standard Deviation 5.0888 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 8 hours, n=42 | 9.379 Nanograms per milliliter | Standard Deviation 3.9554 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 12 hours, n=40 | 8.658 Nanograms per milliliter | Standard Deviation 3.693 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 16 hours, n=42 | 8.225 Nanograms per milliliter | Standard Deviation 3.74 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 1, 24 hours, n=42 | 7.024 Nanograms per milliliter | Standard Deviation 3.5347 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, Predose, n=31 | 1.126 Nanograms per milliliter | Standard Deviation 1.0181 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 0.5 hours, n=30 | 2.472 Nanograms per milliliter | Standard Deviation 2.2298 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506102 | Day 57, 1 hour, n=31 | 2.890 Nanograms per milliliter | Standard Deviation 2.4847 |
Secondary
Plasma Concentrations of Metabolite GSK2506104
Blood samples were collected at indicated time points for the concentrations of metabolite GSK2506104.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 0.5 hours, n=43 | 9.337 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 1 hour, n=43 | 13.263 Nanograms per milliliter | Standard Deviation 20.551 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, Predose, n=45 | 0.000 Nanograms per milliliter | Standard Deviation 0 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 2 hours, n=43 | 28.986 Nanograms per milliliter | Standard Deviation 28.4324 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 3 hours, n=44 | 32.623 Nanograms per milliliter | Standard Deviation 29.1622 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 4 hours, n=43 | 34.266 Nanograms per milliliter | Standard Deviation 27.5021 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 6 hours, n=43 | 37.250 Nanograms per milliliter | Standard Deviation 21.9404 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 8 hours, n=42 | 39.463 Nanograms per milliliter | Standard Deviation 17.2013 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 12 hours, n=40 | 33.822 Nanograms per milliliter | Standard Deviation 16.6962 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 16 hours, n=42 | 31.224 Nanograms per milliliter | Standard Deviation 16.3048 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 1, 24 hours, n=42 | 24.268 Nanograms per milliliter | Standard Deviation 14.2298 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, Predose, n=31 | 4.133 Nanograms per milliliter | Standard Deviation 4.5315 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 0.5 hours, n=31 | 10.759 Nanograms per milliliter | Standard Deviation 11.6369 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 1 hour, n=31 | 12.902 Nanograms per milliliter | Standard Deviation 12.5068 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 2 hours, n=30 | 23.391 Nanograms per milliliter | Standard Deviation 20.1627 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 3 hours, n=31 | 33.561 Nanograms per milliliter | Standard Deviation 26.4516 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 4 hours, n=32 | 41.089 Nanograms per milliliter | Standard Deviation 28.8815 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 6 hours, n=31 | 47.511 Nanograms per milliliter | Standard Deviation 25.5686 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 8 hours, n=31 | 43.646 Nanograms per milliliter | Standard Deviation 22.0075 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 12 hours, n=31 | 39.685 Nanograms per milliliter | Standard Deviation 23.4732 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 16 hours, n=31 | 36.234 Nanograms per milliliter | Standard Deviation 22.183 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2506104 | Day 57, 24 hours, n=32 | 27.808 Nanograms per milliliter | Standard Deviation 14.8739 |
Secondary
Plasma Concentrations of Metabolite GSK2531398
Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531398.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, Predose, n=45 | 0.000 Nanograms per milliliter | Standard Deviation 0 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 0.5 hours, n=43 | 4.409 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 1 hour, n=44 | 6.139 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 2 hours, n=43 | 13.779 Nanograms per milliliter | Standard Deviation 13.5109 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 3 hours, n=44 | 15.087 Nanograms per milliliter | Standard Deviation 13.4427 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 4 hours, n=43 | 14.881 Nanograms per milliliter | Standard Deviation 12.5678 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 6 hours, n=43 | 14.907 Nanograms per milliliter | Standard Deviation 9.6957 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 8 hours, n=42 | 13.930 Nanograms per milliliter | Standard Deviation 7.4098 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 12 hours, n=40 | 9.784 Nanograms per milliliter | Standard Deviation 6.6328 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 16 hours, n=42 | 7.751 Nanograms per milliliter | Standard Deviation 5.9158 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 1, 24 hours, n=42 | 4.687 Nanograms per milliliter | Standard Deviation 4.1099 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, Predose, n=31 | 1.246 Nanograms per milliliter | Standard Deviation 1.9695 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 0.5 hours, n=30 | 4.482 Nanograms per milliliter | Standard Deviation 5.7104 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 1 hour, n=31 | 5.406 Nanograms per milliliter | Standard Deviation 5.8321 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 2 hours, n=30 | 10.580 Nanograms per milliliter | Standard Deviation 10.1185 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 3 hours, n=31 | 15.191 Nanograms per milliliter | Standard Deviation 12.9991 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 4 hours, n=32 | 17.904 Nanograms per milliliter | Standard Deviation 13.4024 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 6 hours, n=30 | 19.827 Nanograms per milliliter | Standard Deviation 11.46 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 8 hours, n=31 | 15.038 Nanograms per milliliter | Standard Deviation 11.0475 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 12 hours, n=31 | 10.292 Nanograms per milliliter | Standard Deviation 8.2309 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 16 hours, n=31 | 8.348 Nanograms per milliliter | Standard Deviation 7.159 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531398 | Day 57, 24 hours, n=32 | 5.334 Nanograms per milliliter | Standard Deviation 4.8807 |
Secondary
Plasma Concentrations of Metabolite GSK2531401
Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531401.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, Predose, n=45 | 0.000 Nanograms per milliliter | Standard Deviation 0 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 0.5 hours, n=43 | 2.927 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 1 hour, n=44 | 4.134 Nanograms per milliliter | — |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 2 hours, n=43 | 11.013 Nanograms per milliliter | Standard Deviation 11.9279 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 3 hours, n=44 | 13.752 Nanograms per milliliter | Standard Deviation 14.0238 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 4 hours, n=43 | 15.497 Nanograms per milliliter | Standard Deviation 14.6142 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 6 hours, n=43 | 18.302 Nanograms per milliliter | Standard Deviation 13.9244 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 8 hours, n=42 | 21.139 Nanograms per milliliter | Standard Deviation 13.2221 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 12 hours, n=40 | 20.174 Nanograms per milliliter | Standard Deviation 11.6828 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 16 hours, n=42 | 20.127 Nanograms per milliliter | Standard Deviation 12.1374 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 1, 24 hours, n=42 | 18.143 Nanograms per milliliter | Standard Deviation 11.6065 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, Predose, n=31 | 2.448 Nanograms per milliliter | Standard Deviation 2.0199 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 0.5 hours, n=31 | 4.486 Nanograms per milliliter | Standard Deviation 3.9244 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 1 hour, n=31 | 5.480 Nanograms per milliliter | Standard Deviation 5.0425 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 2 hours, n=30 | 9.015 Nanograms per milliliter | Standard Deviation 8.4201 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 3 hours, n=31 | 14.027 Nanograms per milliliter | Standard Deviation 12.7046 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 4 hours, n=32 | 17.722 Nanograms per milliliter | Standard Deviation 14.2802 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 6 hours, n=30 | 24.285 Nanograms per milliliter | Standard Deviation 15.7868 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 8 hours, n=31 | 25.557 Nanograms per milliliter | Standard Deviation 16.2248 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 12 hours, n=31 | 25.288 Nanograms per milliliter | Standard Deviation 15.7597 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 16 hours, n=31 | 24.881 Nanograms per milliliter | Standard Deviation 15.3688 |
| Daprodustat | Plasma Concentrations of Metabolite GSK2531401 | Day 57, 24 hours, n=32 | 21.914 Nanograms per milliliter | Standard Deviation 12.9806 |
Secondary
Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 1, n=9 | 6.820 Hours | Geometric Coefficient of Variation 22.096 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 57, n=4 | 7.447 Hours | Geometric Coefficient of Variation 7.539 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 1, n=20 | 3.388 Hours | Geometric Coefficient of Variation 22.165 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 57, n=13 | 3.524 Hours | Geometric Coefficient of Variation 32.634 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 1, n=1 | 8.530 Hours | — |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 57, n=32 | NA Hours | — |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 1, n=1 | 6.150 Hours | — |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 1, n=22 | 3.031 Hours | Geometric Coefficient of Variation 40.32 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 57, n=10 | 3.635 Hours | Geometric Coefficient of Variation 26.884 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 57, n=32 | NA Hours | — |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 1, n=11 | 5.582 Hours | Geometric Coefficient of Variation 22.955 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 57, n=9 | 6.182 Hours | Geometric Coefficient of Variation 14.307 |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 1, n=44 | NA Hours | — |
| Daprodustat | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 57, n=32 | NA Hours | — |
Secondary
Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 1, n=44 | 2.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Daprodustat, Day 57, n=32 | 2.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 1, n=44 | 4.160 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2391220, Day 57, n=32 | 4.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 1, n=44 | 3.090 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2487818, Day 57, n=32 | 4.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 1, n=44 | 6.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506102, Day 57, n=32 | 6.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 1, n=44 | 6.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2506104, Day 57, n=32 | 5.990 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 1, n=44 | 4.160 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531398, Day 57, n=32 | 4.000 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 1, n=44 | 8.015 Hours |
| Daprodustat | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | GSK2531401, Day 57, n=32 | 8.000 Hours |
Other Pre-specified
Absolute Values for Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Baseline (Day1), n=45, 43 | 41.2 Grams per liter | Standard Deviation 3.42 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 29, n=37, 40 | 39.1 Grams per liter | Standard Deviation 3.58 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 57, n=31, 35 | 41.4 Grams per liter | Standard Deviation 4.35 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Week 10, n=39, 38 | 38.7 Grams per liter | Standard Deviation 3.2 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Baseline (Day 1), n=45, 43 | 72.3 Grams per liter | Standard Deviation 7.27 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 29, n=37, 40 | 69.4 Grams per liter | Standard Deviation 5.67 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 57, n=31, 35 | 74.0 Grams per liter | Standard Deviation 7.51 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Week 10, n=39, 38 | 67.5 Grams per liter | Standard Deviation 5.67 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Week 10, n=39, 38 | 67.8 Grams per liter | Standard Deviation 7.79 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Baseline (Day1), n=45, 43 | 40.5 Grams per liter | Standard Deviation 4.21 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Baseline (Day 1), n=45, 43 | 72.6 Grams per liter | Standard Deviation 8.3 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 29, n=37, 40 | 38.3 Grams per liter | Standard Deviation 4.02 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 57, n=31, 35 | 73.1 Grams per liter | Standard Deviation 8.59 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 57, n=31, 35 | 40.9 Grams per liter | Standard Deviation 4.83 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 29, n=37, 40 | 68.0 Grams per liter | Standard Deviation 7.92 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Week 10, n=39, 38 | 38.0 Grams per liter | Standard Deviation 5.19 |
Other Pre-specified
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Day 29, n=37, 40 | 104.4 International units per liter | Standard Deviation 49.97 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Day 57, n=31, 35 | 11.0 International units per liter | Standard Deviation 5.75 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Week 10, n=42, 41 | 98.3 International units per liter | Standard Deviation 54.64 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Week 10, n=42, 41 | 10.6 International units per liter | Standard Deviation 4.71 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Baseline (Day1), n=45, 43 | 100.9 International units per liter | Standard Deviation 51.78 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Baseline (Day 1), n=45, 43 | 16.8 International units per liter | Standard Deviation 6.63 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Baseline (Day 1), n=45, 43 | 13.8 International units per liter | Standard Deviation 6.74 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Day 29, n=37, 40 | 13.2 International units per liter | Standard Deviation 4.76 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Day 57, n=31, 35 | 109.0 International units per liter | Standard Deviation 48.09 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Day 57, n=31, 35 | 14.9 International units per liter | Standard Deviation 5.12 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Day 29, n=37, 40 | 10.4 International units per liter | Standard Deviation 3.95 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Week 10, n=42, 41 | 14.0 International units per liter | Standard Deviation 5.18 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Day 29, n=37, 40 | 12.0 International units per liter | Standard Deviation 5.8 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Baseline (Day1), n=45, 43 | 100.0 International units per liter | Standard Deviation 40.47 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Day 29, n=37, 40 | 95.7 International units per liter | Standard Deviation 37.28 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Day 57, n=31, 35 | 101.7 International units per liter | Standard Deviation 37.81 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALP, Week 10, n=42, 41 | 98.8 International units per liter | Standard Deviation 40.03 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Baseline (Day 1), n=45, 43 | 15.0 International units per liter | Standard Deviation 6.97 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Week 10, n=42, 41 | 15.2 International units per liter | Standard Deviation 10.86 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Day 57, n=31, 35 | 12.9 International units per liter | Standard Deviation 5.07 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT, Week 10, n=42, 41 | 12.3 International units per liter | Standard Deviation 7.01 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Baseline (Day 1), n=45, 43 | 17.0 International units per liter | Standard Deviation 6.07 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Day 29, n=37, 40 | 13.7 International units per liter | Standard Deviation 5.68 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST, Day 57, n=31, 35 | 15.2 International units per liter | Standard Deviation 4.23 |
Other Pre-specified
Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium
Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Day 57, n=31, 35 | 3.81 Millimoles per liter | Standard Deviation 0.414 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Day 57, n=31, 35 | 2.240 Millimoles per liter | Standard Deviation 0.1389 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Week 10, n=39, 38 | 4.66 Millimoles per liter | Standard Deviation 0.639 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Day 29, n=37, 40 | 8.28 Millimoles per liter | Standard Deviation 4.234 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Baseline (Day 1), n=45,43 | 1.129 Millimoles per liter | Standard Deviation 0.4792 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Day 29, n=37, 40 | 2.242 Millimoles per liter | Standard Deviation 0.1692 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 29, n=37, 40 | 1.455 Millimoles per liter | Standard Deviation 0.5207 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Day 57, n=31, 35 | 7.27 Millimoles per liter | Standard Deviation 2.419 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 57, n=31, 35 | 0.953 Millimoles per liter | Standard Deviation 0.2523 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Week 10, n=39, 38 | 2.227 Millimoles per liter | Standard Deviation 0.1599 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Week 10, n=39, 38 | 1.629 Millimoles per liter | Standard Deviation 0.56 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Week 10, n=39, 38 | 7.98 Millimoles per liter | Standard Deviation 3.02 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Baseline (Day 1), n=45,43 | 137.9 Millimoles per liter | Standard Deviation 2.64 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Baseline (Day 1),n=45,43 | 2.254 Millimoles per liter | Standard Deviation 0.1147 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Day 29, n=37, 40 | 137.8 Millimoles per liter | Standard Deviation 2.41 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Baseline (Day 1), n=45,43 | 3.99 Millimoles per liter | Standard Deviation 0.509 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Day 57, n=31, 35 | 137.7 Millimoles per liter | Standard Deviation 2.22 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Baseline (Day 1), n=45,43 | 7.40 Millimoles per liter | Standard Deviation 2.794 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Week 10, n=39, 38 | 137.9 Millimoles per liter | Standard Deviation 2.28 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Day 29, n=37, 40 | 4.39 Millimoles per liter | Standard Deviation 0.769 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Week 10, n=39, 38 | 138.6 Millimoles per liter | Standard Deviation 2.77 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Baseline (Day 1),n=45,43 | 2.266 Millimoles per liter | Standard Deviation 0.1341 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Day 29, n=37, 40 | 2.242 Millimoles per liter | Standard Deviation 0.1479 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Day 57, n=31, 35 | 2.265 Millimoles per liter | Standard Deviation 0.1086 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | CCA, Week 10, n=39, 38 | 2.232 Millimoles per liter | Standard Deviation 0.1644 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Baseline (Day 1), n=45,43 | 7.67 Millimoles per liter | Standard Deviation 3.504 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Day 29, n=37, 40 | 7.35 Millimoles per liter | Standard Deviation 2.362 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Day 57, n=31, 35 | 7.01 Millimoles per liter | Standard Deviation 2.69 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Glucose, Week 10, n=39, 38 | 7.36 Millimoles per liter | Standard Deviation 2.948 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Baseline (Day 1), n=45,43 | 4.06 Millimoles per liter | Standard Deviation 0.788 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Day 57, n=31, 35 | 4.01 Millimoles per liter | Standard Deviation 0.663 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Week 10, n=39, 38 | 4.65 Millimoles per liter | Standard Deviation 0.693 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Baseline (Day 1), n=45,43 | 1.242 Millimoles per liter | Standard Deviation 0.5758 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 29, n=37, 40 | 1.761 Millimoles per liter | Standard Deviation 0.6297 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 57, n=31, 35 | 1.274 Millimoles per liter | Standard Deviation 0.626 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Phosphate, Week 10, n=39, 38 | 1.849 Millimoles per liter | Standard Deviation 0.5431 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Baseline (Day 1), n=45,43 | 138.0 Millimoles per liter | Standard Deviation 2.58 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Day 29, n=37, 40 | 138.4 Millimoles per liter | Standard Deviation 2.84 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Sodium, Day 57, n=31, 35 | 138.6 Millimoles per liter | Standard Deviation 2.74 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Potassium, Day 29, n=37, 40 | 4.60 Millimoles per liter | Standard Deviation 0.765 |
Other Pre-specified
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and Indrt bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin,Baseline(Day1),n=45,43 | 2.0 Micromoles per liter | Standard Deviation 1.24 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin, Day 29, n=37, 39 | 1.9 Micromoles per liter | Standard Deviation 1.05 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin, Day 57, n=31, 35 | 1.9 Micromoles per liter | Standard Deviation 1.21 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin, Week 10, n=39, 38 | 1.8 Micromoles per liter | Standard Deviation 0.89 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Baseline (Day 1),n=45,43 | 8.6 Micromoles per liter | Standard Deviation 3.07 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Day 29, n=37, 39 | 7.1 Micromoles per liter | Standard Deviation 2.19 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Day 57, n=31, 35 | 9.0 Micromoles per liter | Standard Deviation 3.86 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Week 10, n=42, 41 | 7.7 Micromoles per liter | Standard Deviation 2.29 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Baseline (Day 1), n=45,43 | 6.6 Micromoles per liter | Standard Deviation 2.28 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Day 29, n=37, 39 | 5.2 Micromoles per liter | Standard Deviation 1.79 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Day 57, n=31, 35 | 7.0 Micromoles per liter | Standard Deviation 3.3 |
| Daprodustat | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Week 10, n=39, 38 | 5.9 Micromoles per liter | Standard Deviation 2.08 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Day 57, n=31, 35 | 6.9 Micromoles per liter | Standard Deviation 2.02 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin,Baseline(Day1),n=45,43 | 1.8 Micromoles per liter | Standard Deviation 1.17 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Day 57, n=31, 35 | 8.6 Micromoles per liter | Standard Deviation 2.69 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin, Day 29, n=37, 39 | 1.7 Micromoles per liter | Standard Deviation 1.23 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Day 29, n=37, 39 | 5.4 Micromoles per liter | Standard Deviation 1.89 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin, Day 57, n=31, 35 | 1.8 Micromoles per liter | Standard Deviation 1.35 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Week 10, n=42, 41 | 7.0 Micromoles per liter | Standard Deviation 2.2 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Direct bilirubin, Week 10, n=39, 38 | 1.7 Micromoles per liter | Standard Deviation 1.09 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Week 10, n=39, 38 | 5.3 Micromoles per liter | Standard Deviation 1.83 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Baseline (Day 1),n=45,43 | 7.7 Micromoles per liter | Standard Deviation 3.25 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Indrt bilirubin, Baseline (Day 1), n=45,43 | 6.0 Micromoles per liter | Standard Deviation 2.74 |
| Recombinant Human Erythropoietin | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Total bilirubin, Day 29, n=37, 39 | 7.2 Micromoles per liter | Standard Deviation 1.93 |
Other Pre-specified
Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Baseline (Day 1-predose), n=45, 43 | 156.5 Milliseconds | Standard Deviation 30.81 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Day 1: 24 hours, n=39, 38 | 158.1 Milliseconds | Standard Deviation 30.26 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Day 57: predose, n=32, 35 | 155.8 Milliseconds | Standard Deviation 27.69 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Day 57: 24 hours, n=32, 36 | 156.4 Milliseconds | Standard Deviation 29.83 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Week 10, n=39, 40 | 162.5 Milliseconds | Standard Deviation 29.19 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Baseline (Day 1-predose), n=45, 43 | 106.2 Milliseconds | Standard Deviation 18.4 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Day 1: 24 hours, n=40, 38 | 106.0 Milliseconds | Standard Deviation 17.31 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Day 57: predose, n=32, 36 | 106.7 Milliseconds | Standard Deviation 14.46 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Day 57: 24 hours, n=32, 36 | 106.4 Milliseconds | Standard Deviation 15.05 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Week 10, n=39, 40 | 108.5 Milliseconds | Standard Deviation 15.56 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Baseline (Day 1-predose), n=9, 17 | 440.6 Milliseconds | Standard Deviation 22.41 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Day 1: 24 hours, n=7, 11 | 446.1 Milliseconds | Standard Deviation 18.94 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Day 57: predose, n=5, 8 | 452.8 Milliseconds | Standard Deviation 13.92 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Day 57: 24 hours, n=5, 8 | 430.6 Milliseconds | Standard Deviation 14.84 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Week 10, n=6, 10 | 438.8 Milliseconds | Standard Deviation 13.01 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Baseline (Day 1-predose), n=45, 43 | 448.0 Milliseconds | Standard Deviation 40.17 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Day 1: 24 hours, n=40, 38 | 438.9 Milliseconds | Standard Deviation 35.02 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Day 57: predose, n=32, 36 | 442.3 Milliseconds | Standard Deviation 38.12 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Day 57: 24 hours, n=32, 36 | 437.4 Milliseconds | Standard Deviation 33.58 |
| Daprodustat | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Week 10, n=39, 39 | 442.0 Milliseconds | Standard Deviation 37.28 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Day 57: predose, n=32, 36 | 449.1 Milliseconds | Standard Deviation 32.58 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Baseline (Day 1-predose), n=45, 43 | 160.5 Milliseconds | Standard Deviation 30.79 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Baseline (Day 1-predose), n=9, 17 | 429.4 Milliseconds | Standard Deviation 27.49 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Day 1: 24 hours, n=39, 38 | 163.3 Milliseconds | Standard Deviation 34.38 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Baseline (Day 1-predose), n=45, 43 | 445.6 Milliseconds | Standard Deviation 31 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Day 57: predose, n=32, 35 | 152.1 Milliseconds | Standard Deviation 26.9 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Day 1: 24 hours, n=7, 11 | 424.7 Milliseconds | Standard Deviation 27.73 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Day 57: 24 hours, n=32, 36 | 160.3 Milliseconds | Standard Deviation 32.98 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Week 10, n=39, 39 | 441.6 Milliseconds | Standard Deviation 28.11 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | PR interval, Week 10, n=39, 40 | 159.9 Milliseconds | Standard Deviation 31.16 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Day 57: predose, n=5, 8 | 436.1 Milliseconds | Standard Deviation 21.72 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Baseline (Day 1-predose), n=45, 43 | 107.4 Milliseconds | Standard Deviation 16.22 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Day 1: 24 hours, n=40, 38 | 439.3 Milliseconds | Standard Deviation 25.64 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Day 1: 24 hours, n=40, 38 | 107.4 Milliseconds | Standard Deviation 17.85 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Day 57: 24 hours, n=5, 8 | 431.8 Milliseconds | Standard Deviation 31.98 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Day 57: predose, n=32, 36 | 112.4 Milliseconds | Standard Deviation 21.89 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTcB, Day 57: 24 hours, n=32, 36 | 442.0 Milliseconds | Standard Deviation 37.61 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Day 57: 24 hours, n=32, 36 | 111.0 Milliseconds | Standard Deviation 20.75 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QTc interval, Week 10, n=6, 10 | 428.3 Milliseconds | Standard Deviation 31.87 |
| Recombinant Human Erythropoietin | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | QRS duration, Week 10, n=39, 40 | 109.1 Milliseconds | Standard Deviation 20.69 |
Other Pre-specified
Absolute Values for Electrocardiogram (ECG) Mean Heart Rate
Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Day 1: 24 hours, n=40, 38 | 71.6 Beats per minute | Standard Deviation 9.38 |
| Daprodustat | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Day 57: 24 hours, n=32, 36 | 71.2 Beats per minute | Standard Deviation 8.22 |
| Daprodustat | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Day 57: predose, n=32, 36 | 71.2 Beats per minute | Standard Deviation 8.58 |
| Daprodustat | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Week 10, n=39, 40 | 72.3 Beats per minute | Standard Deviation 10.03 |
| Daprodustat | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Baseline (Day 1-predose), n=45, 43 | 72.2 Beats per minute | Standard Deviation 9.52 |
| Recombinant Human Erythropoietin | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Week 10, n=39, 40 | 74.3 Beats per minute | Standard Deviation 9.53 |
| Recombinant Human Erythropoietin | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Baseline (Day 1-predose), n=45, 43 | 73.6 Beats per minute | Standard Deviation 9.03 |
| Recombinant Human Erythropoietin | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Day 1: 24 hours, n=40, 38 | 74.8 Beats per minute | Standard Deviation 9.42 |
| Recombinant Human Erythropoietin | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Day 57: predose, n=32, 36 | 72.7 Beats per minute | Standard Deviation 9.47 |
| Recombinant Human Erythropoietin | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Day 57: 24 hours, n=32, 36 | 75.1 Beats per minute | Standard Deviation 9.12 |
Other Pre-specified
Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr)
Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Baseline (Day 1), n=45, 42 | 31.03 Picograms | Standard Deviation 2.295 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Day 57, n=32, 36 | 30.71 Picograms | Standard Deviation 1.852 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Week 10, n=39, 39 | 30.55 Picograms | Standard Deviation 2.116 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Day 29, n=37, 39 | 31.56 Picograms | Standard Deviation 2.302 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Day 57, n=31, 35 | 31.75 Picograms | Standard Deviation 2.312 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Week 10, n=39, 38 | 31.96 Picograms | Standard Deviation 2.246 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Baseline (Day 1), n=45, 43 | 30.70 Picograms | Standard Deviation 1.73 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Day 29, n=36, 40 | 30.55 Picograms | Standard Deviation 1.799 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Day 29, n=37, 39 | 30.83 Picograms | Standard Deviation 3.051 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Day 29, n=36, 40 | 30.19 Picograms | Standard Deviation 2.242 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Week 10, n=39, 38 | 30.66 Picograms | Standard Deviation 2.823 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Day 57, n=32, 36 | 29.85 Picograms | Standard Deviation 2.462 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Day 57, n=31, 35 | 30.88 Picograms | Standard Deviation 3.14 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Week 10, n=39, 39 | 29.76 Picograms | Standard Deviation 2.079 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | ery. MCH, Baseline (Day 1), n=45, 42 | 30.57 Picograms | Standard Deviation 2.88 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | CHr, Baseline (Day 1), n=45, 43 | 29.97 Picograms | Standard Deviation 2.088 |
Other Pre-specified
Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV)
Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Day 57, n=31, 35 | 96.5 Femtoliters | Standard Deviation 7.18 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Baseline (Day 1), n=45, 42 | 95.0 Femtoliters | Standard Deviation 6.33 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Week 10, n=39, 38 | 97.9 Femtoliters | Standard Deviation 6.61 |
| Daprodustat | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Day 29, n=37, 39 | 96.5 Femtoliters | Standard Deviation 6.92 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Week 10, n=39, 38 | 95.7 Femtoliters | Standard Deviation 8.37 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Baseline (Day 1), n=45, 42 | 94.8 Femtoliters | Standard Deviation 8.37 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Day 57, n=31, 35 | 97.1 Femtoliters | Standard Deviation 9.04 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Day 29, n=37, 39 | 96.2 Femtoliters | Standard Deviation 8.76 |
Other Pre-specified
Absolute Values for Hematology Parameter: Erythrocyte Distribution Width
Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Baseline (Day 1), n=45, 42 | 16.06 Percentage of width | Standard Deviation 1.618 |
| Daprodustat | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Day 29, n=37, 39 | 16.52 Percentage of width | Standard Deviation 1.802 |
| Daprodustat | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Day 57, n=31, 35 | 16.11 Percentage of width | Standard Deviation 1.476 |
| Daprodustat | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Week 10, n=39, 38 | 16.42 Percentage of width | Standard Deviation 2.036 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Week 10, n=39, 38 | 16.45 Percentage of width | Standard Deviation 1.696 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Baseline (Day 1), n=45, 42 | 15.71 Percentage of width | Standard Deviation 1.917 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Day 57, n=31, 35 | 16.67 Percentage of width | Standard Deviation 2.034 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Day 29, n=37, 39 | 16.75 Percentage of width | Standard Deviation 2.23 |
Other Pre-specified
Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1), n=45, 42 | 0.3133 Proportion of red blood cells in blood | Standard Deviation 0.03111 |
| Daprodustat | Absolute Values for Hematology Parameter: Hematocrit | Day 29, n=37, 39 | 0.3066 Proportion of red blood cells in blood | Standard Deviation 0.03195 |
| Daprodustat | Absolute Values for Hematology Parameter: Hematocrit | Day 57, n=31, 35 | 0.3196 Proportion of red blood cells in blood | Standard Deviation 0.03046 |
| Daprodustat | Absolute Values for Hematology Parameter: Hematocrit | Week 10, n=39, 38 | 0.3050 Proportion of red blood cells in blood | Standard Deviation 0.03743 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Hematocrit | Week 10, n=39, 38 | 0.3209 Proportion of red blood cells in blood | Standard Deviation 0.03375 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1), n=45, 42 | 0.3242 Proportion of red blood cells in blood | Standard Deviation 0.03046 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Hematocrit | Day 57, n=31, 35 | 0.3397 Proportion of red blood cells in blood | Standard Deviation 0.02476 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameter: Hematocrit | Day 29, n=37, 39 | 0.3113 Proportion of red blood cells in blood | Standard Deviation 0.03307 |
Other Pre-specified
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 29, n=37, 39 | 0.045 10^9 cells per liter | Standard Deviation 0.0301 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 57, n=30, 35 | 0.432 10^9 cells per liter | Standard Deviation 0.1621 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 57, n=30, 35 | 0.218 10^9 cells per liter | Standard Deviation 0.1811 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Week 10, n=39, 38 | 0.469 10^9 cells per liter | Standard Deviation 0.164 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Week 10, n=39, 38 | 6.35 10^9 cells per liter | Standard Deviation 2.178 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day 1), n=45, 41 | 4.091 10^9 cells per liter | Standard Deviation 1.6571 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Week 10, n=39, 38 | 0.231 10^9 cells per liter | Standard Deviation 0.1918 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 29, n=37, 39 | 4.319 10^9 cells per liter | Standard Deviation 1.3509 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 57, n=30, 35 | 0.049 10^9 cells per liter | Standard Deviation 0.0349 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 57, n=30, 35 | 4.381 10^9 cells per liter | Standard Deviation 1.9926 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Baseline (Day 1), n=45, 41 | 1.257 10^9 cells per liter | Standard Deviation 0.3926 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Week 10, n=39, 38 | 4.250 10^9 cells per liter | Standard Deviation 1.8123 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Week 10, n=39, 38 | 0.044 10^9 cells per liter | Standard Deviation 0.0261 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Baseline (Day 1), n=45, 42 | 188.5 10^9 cells per liter | Standard Deviation 67.64 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 29, n=37, 39 | 1.385 10^9 cells per liter | Standard Deviation 0.5446 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 29, n=37, 38 | 195.2 10^9 cells per liter | Standard Deviation 66.55 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Baseline (Day 1), n=45, 41 | 0.050 10^9 cells per liter | Standard Deviation 0.0295 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 57, n=30, 34 | 207.8 10^9 cells per liter | Standard Deviation 95.04 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 57, n=30, 35 | 1.209 10^9 cells per liter | Standard Deviation 0.5062 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Week 10, n=39, 38 | 209.3 10^9 cells per liter | Standard Deviation 75.61 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Baseline (Day 1), n=45, 41 | 0.196 10^9 cells per liter | Standard Deviation 0.152 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day 1), n=45, 41 | 6.00 10^9 cells per liter | Standard Deviation 1.923 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Week 10, n=39, 38 | 1.367 10^9 cells per liter | Standard Deviation 0.5559 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 29, n=37, 39 | 6.43 10^9 cells per liter | Standard Deviation 1.678 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 29, n=37, 39 | 0.442 10^9 cells per liter | Standard Deviation 0.1664 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 57, n=30, 35 | 6.29 10^9 cells per liter | Standard Deviation 2.363 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Baseline (Day 1), n=45, 41 | 0.398 10^9 cells per liter | Standard Deviation 0.1471 |
| Daprodustat | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 29, n=37, 39 | 0.238 10^9 cells per liter | Standard Deviation 0.2301 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Week 10, n=39, 38 | 6.45 10^9 cells per liter | Standard Deviation 2.297 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Baseline (Day 1), n=45, 41 | 0.044 10^9 cells per liter | Standard Deviation 0.0255 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 29, n=37, 39 | 0.054 10^9 cells per liter | Standard Deviation 0.0312 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Week 10, n=39, 38 | 0.054 10^9 cells per liter | Standard Deviation 0.0284 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Baseline (Day 1), n=45, 41 | 0.229 10^9 cells per liter | Standard Deviation 0.2324 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 29, n=37, 39 | 0.191 10^9 cells per liter | Standard Deviation 0.1551 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 57, n=30, 35 | 0.160 10^9 cells per liter | Standard Deviation 0.1505 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Week 10, n=39, 38 | 0.184 10^9 cells per liter | Standard Deviation 0.1167 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Baseline (Day 1), n=45, 41 | 1.307 10^9 cells per liter | Standard Deviation 0.6305 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 29, n=37, 39 | 1.436 10^9 cells per liter | Standard Deviation 0.5798 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 57, n=30, 35 | 1.225 10^9 cells per liter | Standard Deviation 0.6698 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Week 10, n=39, 38 | 1.408 10^9 cells per liter | Standard Deviation 0.6788 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Baseline (Day 1), n=45, 41 | 0.408 10^9 cells per liter | Standard Deviation 0.1752 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 29, n=37, 39 | 0.460 10^9 cells per liter | Standard Deviation 0.1812 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 57, n=30, 35 | 0.448 10^9 cells per liter | Standard Deviation 0.2204 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Week 10, n=39, 38 | 0.443 10^9 cells per liter | Standard Deviation 0.1773 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day 1), n=45, 41 | 4.053 10^9 cells per liter | Standard Deviation 1.4574 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 29, n=37, 39 | 4.242 10^9 cells per liter | Standard Deviation 1.5623 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 57, n=30, 35 | 4.377 10^9 cells per liter | Standard Deviation 1.645 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Week 10, n=39, 38 | 4.369 10^9 cells per liter | Standard Deviation 1.7463 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Baseline (Day 1), n=45, 42 | 193.8 10^9 cells per liter | Standard Deviation 70.03 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 29, n=37, 38 | 222.1 10^9 cells per liter | Standard Deviation 82.78 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 57, n=30, 34 | 213.5 10^9 cells per liter | Standard Deviation 67.33 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Week 10, n=39, 38 | 229.5 10^9 cells per liter | Standard Deviation 78.29 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day 1), n=45, 41 | 6.04 10^9 cells per liter | Standard Deviation 1.897 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 29, n=37, 39 | 6.38 10^9 cells per liter | Standard Deviation 2.145 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 57, n=30, 35 | 6.25 10^9 cells per liter | Standard Deviation 2.044 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 57, n=30, 35 | 0.045 10^9 cells per liter | Standard Deviation 0.0243 |
Other Pre-specified
Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes
Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Baseline (Day 1), n=45, 42 | 3.31 10^12 cells per liter | Standard Deviation 0.378 |
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 57, n=31, 35 | 3.34 10^12 cells per liter | Standard Deviation 0.393 |
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 29, n=37, 39 | 0.0486 10^12 cells per liter | Standard Deviation 0.01676 |
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 29, n=37, 39 | 3.20 10^12 cells per liter | Standard Deviation 0.361 |
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 57, n=31, 35 | 0.0489 10^12 cells per liter | Standard Deviation 0.01681 |
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Week 10, n=39, 38 | 3.13 10^12 cells per liter | Standard Deviation 0.388 |
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Week 10, n=39, 38 | 0.0613 10^12 cells per liter | Standard Deviation 0.03932 |
| Daprodustat | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Baseline (Day 1), n=45, 42 | 0.0302 10^12 cells per liter | Standard Deviation 0.01536 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Week 10, n=39, 38 | 0.0566 10^12 cells per liter | Standard Deviation 0.0306 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Baseline (Day 1), n=45, 42 | 3.45 10^12 cells per liter | Standard Deviation 0.388 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 29, n=37, 39 | 3.27 10^12 cells per liter | Standard Deviation 0.499 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 57, n=31, 35 | 3.53 10^12 cells per liter | Standard Deviation 0.357 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Week 10, n=39, 38 | 3.38 10^12 cells per liter | Standard Deviation 0.47 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Baseline (Day 1), n=45, 42 | 0.0401 10^12 cells per liter | Standard Deviation 0.02614 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 29, n=37, 39 | 0.0733 10^12 cells per liter | Standard Deviation 0.03493 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 57, n=31, 35 | 0.0627 10^12 cells per liter | Standard Deviation 0.03344 |
Other Pre-specified
Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC)
Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Baseline (Day 1), n=45, 42 | 326.7 Grams per liter | Standard Deviation 9.01 |
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Week 10, n=39, 38 | 99.6 Grams per liter | Standard Deviation 12.44 |
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Day 29, n=37, 39 | 327.1 Grams per liter | Standard Deviation 6.57 |
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Day 29, n=37, 39 | 100.2 Grams per liter | Standard Deviation 10.01 |
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Day 57, n=31, 35 | 329.0 Grams per liter | Standard Deviation 6.62 |
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Baseline (Day 1), n=45, 42 | 102.2 Grams per liter | Standard Deviation 9.15 |
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Week 10, n=39, 38 | 326.7 Grams per liter | Standard Deviation 9.26 |
| Daprodustat | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Day 57, n=31, 35 | 105.2 Grams per liter | Standard Deviation 9.61 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Week 10, n=39, 38 | 320.6 Grams per liter | Standard Deviation 9.17 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Week 10, n=39, 38 | 102.9 Grams per liter | Standard Deviation 10.54 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Baseline (Day 1), n=45, 42 | 104.5 Grams per liter | Standard Deviation 8.83 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Day 29, n=37, 39 | 99.7 Grams per liter | Standard Deviation 9.63 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Baseline (Day 1), n=45, 42 | 322.6 Grams per liter | Standard Deviation 8.41 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Day 29, n=37, 39 | 320.8 Grams per liter | Standard Deviation 11.5 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | ery.MCHC, Day 57, n=31, 35 | 318.3 Grams per liter | Standard Deviation 15.46 |
| Recombinant Human Erythropoietin | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Hemoglobin, Day 57, n=31, 35 | 107.9 Grams per liter | Standard Deviation 6.01 |
Other Pre-specified
Absolute Values for Pulse Rate
Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1, predose) and at Day 1:3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Pulse Rate | Day 1: 3 hours, n=44, 43 | 72.48 Beats per minute | Standard Deviation 9.931 |
| Daprodustat | Absolute Values for Pulse Rate | Day 57: pre-dialysis, n=32, 36 | 74.59 Beats per minute | Standard Deviation 12.793 |
| Daprodustat | Absolute Values for Pulse Rate | Day 1: 24 hours, n=41, 40 | 73.37 Beats per minute | Standard Deviation 10.495 |
| Daprodustat | Absolute Values for Pulse Rate | Day 57: post dialysis, n=32, 36 | 72.63 Beats per minute | Standard Deviation 10.354 |
| Daprodustat | Absolute Values for Pulse Rate | Baseline (Day1, predose), n=45, 43 | 72.09 Beats per minute | Standard Deviation 9.86 |
| Daprodustat | Absolute Values for Pulse Rate | Day 57: 3 hours, n=32, 36 | 70.91 Beats per minute | Standard Deviation 11.36 |
| Daprodustat | Absolute Values for Pulse Rate | Day 29: pre-dialysis, n=38, 40 | 72.92 Beats per minute | Standard Deviation 11.751 |
| Daprodustat | Absolute Values for Pulse Rate | Day 57: 24 hours, n=32, 36 | 71.16 Beats per minute | Standard Deviation 10.097 |
| Daprodustat | Absolute Values for Pulse Rate | Day1: 12 hours, n=44, 43 | 71.95 Beats per minute | Standard Deviation 9.101 |
| Daprodustat | Absolute Values for Pulse Rate | Week 10: pre-dialysis, n=42, 42 | 73.07 Beats per minute | Standard Deviation 10.744 |
| Daprodustat | Absolute Values for Pulse Rate | Day 29: post dialysis, n=38, 40 | 74.00 Beats per minute | Standard Deviation 10.051 |
| Daprodustat | Absolute Values for Pulse Rate | Week 10: post dialysis, n=41, 42 | 71.76 Beats per minute | Standard Deviation 10.138 |
| Daprodustat | Absolute Values for Pulse Rate | Day 57: 12 hours, n=32, 36 | 70.50 Beats per minute | Standard Deviation 11.259 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Week 10: post dialysis, n=41, 42 | 74.55 Beats per minute | Standard Deviation 11.096 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 57: 3 hours, n=32, 36 | 75.25 Beats per minute | Standard Deviation 9.755 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Baseline (Day1, predose), n=45, 43 | 76.19 Beats per minute | Standard Deviation 11.45 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 1: 3 hours, n=44, 43 | 76.21 Beats per minute | Standard Deviation 10.432 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day1: 12 hours, n=44, 43 | 72.65 Beats per minute | Standard Deviation 9.564 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 1: 24 hours, n=41, 40 | 76.43 Beats per minute | Standard Deviation 8.388 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 29: pre-dialysis, n=38, 40 | 76.05 Beats per minute | Standard Deviation 8.688 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 29: post dialysis, n=38, 40 | 76.18 Beats per minute | Standard Deviation 11.437 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 57: pre-dialysis, n=32, 36 | 77.17 Beats per minute | Standard Deviation 10.997 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 57: post dialysis, n=32, 36 | 75.75 Beats per minute | Standard Deviation 9.927 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 57: 12 hours, n=32, 36 | 75.11 Beats per minute | Standard Deviation 9.858 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Day 57: 24 hours, n=32, 36 | 75.36 Beats per minute | Standard Deviation 7.65 |
| Recombinant Human Erythropoietin | Absolute Values for Pulse Rate | Week 10: pre-dialysis, n=42, 42 | 75.81 Beats per minute | Standard Deviation 9.823 |
Other Pre-specified
Absolute Values for Temperature
Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Temperature | Day1: 12 hours, n=44, 43 | 36.470 Degrees celsius | Standard Deviation 0.4032 |
| Daprodustat | Absolute Values for Temperature | Day 57: post dialysis, n=32, 36 | 36.384 Degrees celsius | Standard Deviation 0.3028 |
| Daprodustat | Absolute Values for Temperature | Day 29: pre-dialysis, n=38, 40 | 36.389 Degrees celsius | Standard Deviation 0.3547 |
| Daprodustat | Absolute Values for Temperature | Day 57: 3 hours, n=32, 36 | 36.422 Degrees celsius | Standard Deviation 0.3066 |
| Daprodustat | Absolute Values for Temperature | Day 1: 3 hours, n=44, 43 | 36.427 Degrees celsius | Standard Deviation 0.348 |
| Daprodustat | Absolute Values for Temperature | Day 57: 12 hours, n=32, 36 | 36.525 Degrees celsius | Standard Deviation 0.4363 |
| Daprodustat | Absolute Values for Temperature | Day 29: post dialysis, n=38, 40 | 36.316 Degrees celsius | Standard Deviation 0.3576 |
| Daprodustat | Absolute Values for Temperature | Day 57: 24 hours, n=32, 36 | 36.447 Degrees celsius | Standard Deviation 0.336 |
| Daprodustat | Absolute Values for Temperature | Day 1: 24 hours, n=41, 40 | 36.459 Degrees celsius | Standard Deviation 0.3598 |
| Daprodustat | Absolute Values for Temperature | Week 10: pre-dialysis, n=42, 42 | 36.414 Degrees celsius | Standard Deviation 0.3375 |
| Daprodustat | Absolute Values for Temperature | Day 57: pre-dialysis, n=32, 36 | 36.419 Degrees celsius | Standard Deviation 0.3685 |
| Daprodustat | Absolute Values for Temperature | Week 10: post dialysis, n=41, 42 | 36.461 Degrees celsius | Standard Deviation 0.3767 |
| Daprodustat | Absolute Values for Temperature | Baseline (Day1, predose), n=45, 43 | 36.456 Degrees celsius | Standard Deviation 0.3708 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Week 10: post dialysis, n=41, 42 | 36.450 Degrees celsius | Standard Deviation 0.2625 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Baseline (Day1, predose), n=45, 43 | 36.442 Degrees celsius | Standard Deviation 0.3692 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 1: 3 hours, n=44, 43 | 36.374 Degrees celsius | Standard Deviation 0.3102 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day1: 12 hours, n=44, 43 | 36.507 Degrees celsius | Standard Deviation 0.4125 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 1: 24 hours, n=41, 40 | 36.380 Degrees celsius | Standard Deviation 0.3539 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 29: pre-dialysis, n=38, 40 | 36.418 Degrees celsius | Standard Deviation 0.3169 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 29: post dialysis, n=38, 40 | 36.380 Degrees celsius | Standard Deviation 0.304 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 57: pre-dialysis, n=32, 36 | 36.403 Degrees celsius | Standard Deviation 0.341 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 57: post dialysis, n=32, 36 | 36.378 Degrees celsius | Standard Deviation 0.2977 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 57: 3 hours, n=32, 36 | 36.497 Degrees celsius | Standard Deviation 0.4018 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 57: 12 hours, n=32, 36 | 36.414 Degrees celsius | Standard Deviation 0.3474 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Day 57: 24 hours, n=32, 36 | 36.506 Degrees celsius | Standard Deviation 0.3014 |
| Recombinant Human Erythropoietin | Absolute Values for Temperature | Week 10: pre-dialysis, n=42, 42 | 36.383 Degrees celsius | Standard Deviation 0.2469 |
Other Pre-specified
Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment.
Time frame: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day1: 12 hours, n=44, 43 | 77.11 Millimeters of mercury | Standard Deviation 13.784 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: 24 hours, n=32, 36 | 143.78 Millimeters of mercury | Standard Deviation 17.783 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 10: pre-dialysis, n=42, 42 | 142.71 Millimeters of mercury | Standard Deviation 20.123 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 10: post dialysis, n=41, 42 | 138.73 Millimeters of mercury | Standard Deviation 19.584 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Baseline (Day1, predose), n=45, 43 | 70.00 Millimeters of mercury | Standard Deviation 10.967 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1: 3 hours, n=44, 43 | 74.91 Millimeters of mercury | Standard Deviation 12.676 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: 12 hours, n=32, 36 | 130.47 Millimeters of mercury | Standard Deviation 22.492 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1: 24 hours, n=41, 40 | 74.22 Millimeters of mercury | Standard Deviation 11.01 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 29: pre-dialysis, n=38, 40 | 71.92 Millimeters of mercury | Standard Deviation 10.794 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 29: post dialysis, n=38, 40 | 69.47 Millimeters of mercury | Standard Deviation 11.272 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: pre-dialysis, n=32, 36 | 72.69 Millimeters of mercury | Standard Deviation 9.855 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: post dialysis, n=32, 36 | 71.47 Millimeters of mercury | Standard Deviation 10.586 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: 3 hours, n=32, 36 | 72.44 Millimeters of mercury | Standard Deviation 13.023 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: 12 hours, n=32, 36 | 67.38 Millimeters of mercury | Standard Deviation 10.536 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: 24 hours, n=32, 36 | 76.44 Millimeters of mercury | Standard Deviation 12.425 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 10: pre-dialysis, n=42, 42 | 73.86 Millimeters of mercury | Standard Deviation 12.479 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 10: post dialysis, n=41, 42 | 71.05 Millimeters of mercury | Standard Deviation 12.008 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Baseline (Day1, predose), n=45, 43 | 135.87 Millimeters of mercury | Standard Deviation 20.813 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1: 3 hours, n=44, 43 | 140.64 Millimeters of mercury | Standard Deviation 18.183 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day1: 12 hours, n=44, 43 | 142.05 Millimeters of mercury | Standard Deviation 23.15 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1: 24 hours, n=41, 40 | 140.24 Millimeters of mercury | Standard Deviation 20.96 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 29: pre-dialysis, n=38, 40 | 143.05 Millimeters of mercury | Standard Deviation 20.351 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 29: post dialysis, n=38, 40 | 130.97 Millimeters of mercury | Standard Deviation 20.608 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: pre-dialysis, n=32, 36 | 142.75 Millimeters of mercury | Standard Deviation 22.599 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: post dialysis, n=32, 36 | 135.66 Millimeters of mercury | Standard Deviation 18.314 |
| Daprodustat | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: 3 hours, n=32, 36 | 140.94 Millimeters of mercury | Standard Deviation 22.623 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day1: 12 hours, n=44, 43 | 143.56 Millimeters of mercury | Standard Deviation 20.566 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: 12 hours, n=32, 36 | 145.47 Millimeters of mercury | Standard Deviation 18.599 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: 12 hours, n=32, 36 | 75.94 Millimeters of mercury | Standard Deviation 10.376 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: 24 hours, n=32, 36 | 144.83 Millimeters of mercury | Standard Deviation 15.497 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: post dialysis, n=32, 36 | 141.64 Millimeters of mercury | Standard Deviation 20.304 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 10: pre-dialysis, n=42, 42 | 147.12 Millimeters of mercury | Standard Deviation 18.285 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: 24 hours, n=32, 36 | 74.81 Millimeters of mercury | Standard Deviation 8.756 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 10: post dialysis, n=41, 42 | 136.74 Millimeters of mercury | Standard Deviation 22.105 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1: 24 hours, n=41, 40 | 142.05 Millimeters of mercury | Standard Deviation 14.822 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Baseline (Day1, predose), n=45, 43 | 72.05 Millimeters of mercury | Standard Deviation 11.307 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 10: pre-dialysis, n=42, 42 | 75.83 Millimeters of mercury | Standard Deviation 10.087 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1: 3 hours, n=44, 43 | 75.53 Millimeters of mercury | Standard Deviation 11.701 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: pre-dialysis, n=32, 36 | 151.53 Millimeters of mercury | Standard Deviation 19.893 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day1: 12 hours, n=44, 43 | 77.19 Millimeters of mercury | Standard Deviation 12.557 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 10: post dialysis, n=41, 42 | 69.52 Millimeters of mercury | Standard Deviation 10.341 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1: 24 hours, n=41, 40 | 76.18 Millimeters of mercury | Standard Deviation 10.318 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 29: pre-dialysis, n=38, 40 | 148.10 Millimeters of mercury | Standard Deviation 20.445 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 29: pre-dialysis, n=38, 40 | 77.95 Millimeters of mercury | Standard Deviation 12.85 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Baseline (Day1, predose), n=45, 43 | 137.00 Millimeters of mercury | Standard Deviation 16.547 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 29: post dialysis, n=38, 40 | 73.30 Millimeters of mercury | Standard Deviation 10.823 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 57: 3 hours, n=32, 36 | 148.06 Millimeters of mercury | Standard Deviation 20.316 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: pre-dialysis, n=32, 36 | 76.69 Millimeters of mercury | Standard Deviation 12.578 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1: 3 hours, n=44, 43 | 144.05 Millimeters of mercury | Standard Deviation 22.184 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: post dialysis, n=32, 36 | 72.56 Millimeters of mercury | Standard Deviation 10.383 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 29: post dialysis, n=38, 40 | 141.93 Millimeters of mercury | Standard Deviation 19.038 |
| Recombinant Human Erythropoietin | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 57: 3 hours, n=32, 36 | 75.72 Millimeters of mercury | Standard Deviation 11.732 |
Other Pre-specified
Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 29, n=37, 40 | -3.7 Grams per liter | Standard Deviation 6.41 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 29, n=37, 40 | -2.2 Grams per liter | Standard Deviation 3.67 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 57, n=31, 35 | 1.2 Grams per liter | Standard Deviation 6.44 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Week 10, n=39, 38 | -2.9 Grams per liter | Standard Deviation 3.1 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Week 10, n=39, 38 | -5.2 Grams per liter | Standard Deviation 5.9 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 57, n=31, 35 | 0.4 Grams per liter | Standard Deviation 3.6 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Week 10, n=39, 38 | -4.9 Grams per liter | Standard Deviation 5.69 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 57, n=31, 35 | 0.5 Grams per liter | Standard Deviation 3.16 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Week 10, n=39, 38 | -2.4 Grams per liter | Standard Deviation 3.93 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 29, n=37, 40 | -4.7 Grams per liter | Standard Deviation 6.03 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Protein, Day 57, n=31, 35 | 0.7 Grams per liter | Standard Deviation 5.64 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day 29, n=37, 40 | -2.4 Grams per liter | Standard Deviation 3.42 |
Other Pre-specified
Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST
Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALP, Week 10, n=42, 41 | -4.5 International units per liter | Standard Deviation 29.46 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALT, Week 10, n=42, 41 | -3.3 International units per liter | Standard Deviation 7.31 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALP, Day 57, n=31, 35 | 0.5 International units per liter | Standard Deviation 23.21 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | AST, Day 29, n=37, 40 | -3.2 International units per liter | Standard Deviation 4.9 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALT, Day 29, n=37, 40 | -3.2 International units per liter | Standard Deviation 5.74 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | AST, Day 57, n=31, 35 | -2.1 International units per liter | Standard Deviation 6.1 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALP, Day 29, n=37, 40 | -3.4 International units per liter | Standard Deviation 19.56 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | AST, Week 10, n=42, 41 | -3.3 International units per liter | Standard Deviation 6.1 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALT, Day 57, n=31, 35 | -3.1 International units per liter | Standard Deviation 7.93 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | AST, Week 10, n=42, 41 | -2.0 International units per liter | Standard Deviation 9.11 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALP, Day 29, n=37, 40 | -5.3 International units per liter | Standard Deviation 27.57 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALP, Day 57, n=31, 35 | 3.4 International units per liter | Standard Deviation 17.93 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALP, Week 10, n=42, 41 | -1.9 International units per liter | Standard Deviation 25.7 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALT, Day 29, n=37, 40 | -2.6 International units per liter | Standard Deviation 6.36 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALT, Day 57, n=31, 35 | -1.9 International units per liter | Standard Deviation 5.93 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | ALT, Week 10, n=42, 41 | -2.8 International units per liter | Standard Deviation 4.96 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | AST, Day 29, n=37, 40 | -3.0 International units per liter | Standard Deviation 5.38 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | AST, Day 57, n=31, 35 | -1.9 International units per liter | Standard Deviation 4.6 |
Other Pre-specified
Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium
Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Glucose, Day 57, n=31, 35 | -0.45 Millimoles per liter | Standard Deviation 2.403 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Potassium, Week 10, n=39, 38 | 0.67 Millimoles per liter | Standard Deviation 0.694 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | CCA, Day 57, n=31, 35 | 0.004 Millimoles per liter | Standard Deviation 0.1344 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 29, n=37, 40 | 0.389 Millimoles per liter | Standard Deviation 0.6876 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Glucose, Week 10, n=39, 38 | 0.62 Millimoles per liter | Standard Deviation 3.001 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 57, n=31, 35 | -0.123 Millimoles per liter | Standard Deviation 0.4624 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Glucose, Day 29, n=37, 40 | 0.75 Millimoles per liter | Standard Deviation 4.331 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Phosphate, Week 10, n=39, 38 | 0.505 Millimoles per liter | Standard Deviation 0.7016 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Potassium, Day 29, n=37, 40 | 0.45 Millimoles per liter | Standard Deviation 0.79 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Sodium, Day 29, n=37, 40 | -0.1 Millimoles per liter | Standard Deviation 3.25 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | CCA, Week 10, n=39, 38 | -0.010 Millimoles per liter | Standard Deviation 0.1693 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Sodium, Day 57, n=31, 35 | 0.2 Millimoles per liter | Standard Deviation 2.47 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Potassium, Day 57, n=31, 35 | -0.14 Millimoles per liter | Standard Deviation 0.512 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Sodium, Week 10, n=39, 38 | -0.2 Millimoles per liter | Standard Deviation 2.41 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | CCA, Day 29, n=37, 40 | 0.000 Millimoles per liter | Standard Deviation 0.1384 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Sodium, Week 10, n=39, 38 | 0.5 Millimoles per liter | Standard Deviation 2.53 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | CCA, Day 29, n=37, 40 | -0.021 Millimoles per liter | Standard Deviation 0.1699 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | CCA, Day 57, n=31, 35 | -0.000 Millimoles per liter | Standard Deviation 0.145 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | CCA, Week 10, n=39, 38 | -0.033 Millimoles per liter | Standard Deviation 0.1284 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Glucose, Day 29, n=37, 40 | -0.48 Millimoles per liter | Standard Deviation 3.771 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Glucose, Day 57, n=31, 35 | -0.83 Millimoles per liter | Standard Deviation 2.684 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Glucose, Week 10, n=39, 38 | -0.18 Millimoles per liter | Standard Deviation 2.916 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Potassium, Day 29, n=37, 40 | 0.53 Millimoles per liter | Standard Deviation 0.863 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Potassium, Day 57, n=31, 35 | -0.04 Millimoles per liter | Standard Deviation 0.696 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Potassium, Week 10, n=39, 38 | 0.58 Millimoles per liter | Standard Deviation 0.746 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 29, n=37, 40 | 0.513 Millimoles per liter | Standard Deviation 0.727 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Phosphate, Day 57, n=31, 35 | 0.004 Millimoles per liter | Standard Deviation 0.5274 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Phosphate, Week 10, n=39, 38 | 0.599 Millimoles per liter | Standard Deviation 0.6723 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Sodium, Day 29, n=37, 40 | 0.3 Millimoles per liter | Standard Deviation 3.22 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Sodium, Day 57, n=31, 35 | 0.6 Millimoles per liter | Standard Deviation 2.71 |
Other Pre-specified
Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and indrt. bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Total bilirubin, Day 57, n=31, 35 | 0.6 Micromoles per liter | Standard Deviation 2.74 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Total bilirubin, Week 10, n=42, 41 | -1.0 Micromoles per liter | Standard Deviation 2.62 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Direct bilirubin, Day 29, n=37, 39 | -0.1 Micromoles per liter | Standard Deviation 1.05 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Direct bilirubin, Day 57, n=31, 35 | -0.1 Micromoles per liter | Standard Deviation 1.21 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Direct bilirubin, Week 10, n=39, 38 | -0.3 Micromoles per liter | Standard Deviation 1.14 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Total bilirubin, Day 29, n=37, 39 | -1.5 Micromoles per liter | Standard Deviation 2.19 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Indrt bilirubin, Day 29, n=37, 39 | -1.4 Micromoles per liter | Standard Deviation 2.06 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Indrt bilirubin, Day 57, n=31, 35 | 0.6 Micromoles per liter | Standard Deviation 2.8 |
| Daprodustat | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Indrt bilirubin, Week 10, n=39, 38 | -0.8 Micromoles per liter | Standard Deviation 2.28 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Indrt bilirubin, Week 10, n=39, 38 | -0.5 Micromoles per liter | Standard Deviation 2.01 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Total bilirubin, Day 57, n=31, 35 | 0.7 Micromoles per liter | Standard Deviation 2.7 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Total bilirubin, Day 29, n=37, 39 | -0.8 Micromoles per liter | Standard Deviation 3.1 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Total bilirubin, Week 10, n=42, 41 | -0.8 Micromoles per liter | Standard Deviation 2.23 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Direct bilirubin, Day 29, n=37, 39 | -0.1 Micromoles per liter | Standard Deviation 1.69 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Indrt bilirubin, Day 57, n=31, 35 | 0.9 Micromoles per liter | Standard Deviation 2.8 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Direct bilirubin, Day 57, n=31, 35 | -0.1 Micromoles per liter | Standard Deviation 1.37 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Indrt bilirubin, Day 29, n=37, 39 | -0.7 Micromoles per liter | Standard Deviation 2.92 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Direct bilirubin, Week 10, n=39, 38 | -0.1 Micromoles per liter | Standard Deviation 1.18 |
Other Pre-specified
Change From Baseline Values for ECG Mean Heart Rate
Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for ECG Mean Heart Rate | Day 57: 24 hours, n=32, 36 | -1.7 Beats per minute | Standard Deviation 6.58 |
| Daprodustat | Change From Baseline Values for ECG Mean Heart Rate | Day 1: 24 hours, n=40, 38 | -0.6 Beats per minute | Standard Deviation 6.85 |
| Daprodustat | Change From Baseline Values for ECG Mean Heart Rate | Week 10, n=39, 40 | -0.1 Beats per minute | Standard Deviation 9.01 |
| Daprodustat | Change From Baseline Values for ECG Mean Heart Rate | Day 57: predose, n=32, 36 | -1.6 Beats per minute | Standard Deviation 7.25 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Mean Heart Rate | Week 10, n=39, 40 | 0.4 Beats per minute | Standard Deviation 8.86 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Mean Heart Rate | Day 1: 24 hours, n=40, 38 | 0.8 Beats per minute | Standard Deviation 5.61 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Mean Heart Rate | Day 57: 24 hours, n=32, 36 | 2.5 Beats per minute | Standard Deviation 8.21 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Mean Heart Rate | Day 57: predose, n=32, 36 | 0.1 Beats per minute | Standard Deviation 8.22 |
Other Pre-specified
Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB
Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Day 1: 24 hours, n=39, 38 | 3.0 Milliseconds | Standard Deviation 11.02 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Day 57: predose, n=32, 35 | 0.2 Milliseconds | Standard Deviation 17.58 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Day 57: 24 hours, n=32, 36 | 0.8 Milliseconds | Standard Deviation 15.89 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Week 10, n=39, 40 | 4.9 Milliseconds | Standard Deviation 15.21 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Day 1: 24 hours, n=40, 38 | -0.5 Milliseconds | Standard Deviation 7.6 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Day 57: predose, n=32, 36 | 0.3 Milliseconds | Standard Deviation 9.53 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Day 57: 24 hours, n=32, 36 | 0.0 Milliseconds | Standard Deviation 11.13 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Week 10, n=39, 40 | 0.8 Milliseconds | Standard Deviation 12.62 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Day 1: 24 hours, n=7, 11 | 2.1 Milliseconds | Standard Deviation 14.59 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Day 57: predose, n=4, 8 | -6.3 Milliseconds | Standard Deviation 20.14 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Day 57: 24 hours, n=4, 8 | -29.0 Milliseconds | Standard Deviation 31.89 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Week 10, n=6, 9 | -6.7 Milliseconds | Standard Deviation 25.15 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Day 1: 24 hours, n=40, 38 | -7.0 Milliseconds | Standard Deviation 24.13 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Day 57: predose, n=32, 36 | -7.0 Milliseconds | Standard Deviation 30.14 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Day 57: 24 hours, n=32, 36 | -12.0 Milliseconds | Standard Deviation 29.93 |
| Daprodustat | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Week 10, n=39, 39 | -7.2 Milliseconds | Standard Deviation 35.84 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Week 10, n=39, 39 | -3.0 Milliseconds | Standard Deviation 15.34 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Day 1: 24 hours, n=39, 38 | 1.9 Milliseconds | Standard Deviation 11.16 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Day 1: 24 hours, n=7, 11 | -9.4 Milliseconds | Standard Deviation 14.87 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Day 57: predose, n=32, 35 | -3.9 Milliseconds | Standard Deviation 11.34 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Day 1: 24 hours, n=40, 38 | -3.1 Milliseconds | Standard Deviation 12.31 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Day 57: 24 hours, n=32, 36 | 1.8 Milliseconds | Standard Deviation 13.03 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Day 57: predose, n=4, 8 | 1.0 Milliseconds | Standard Deviation 5.71 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | PR interval, Week 10, n=39, 40 | 1.2 Milliseconds | Standard Deviation 17.11 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Day 57: 24 hours, n=32, 36 | -2.2 Milliseconds | Standard Deviation 23.15 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Day 1: 24 hours, n=40, 38 | 0.0 Milliseconds | Standard Deviation 4.73 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Day 57: 24 hours, n=4, 8 | -3.4 Milliseconds | Standard Deviation 14.79 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Day 57: predose, n=32, 36 | 2.8 Milliseconds | Standard Deviation 15.01 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTcB, Day 57: predose, n=32, 36 | 4.9 Milliseconds | Standard Deviation 12.36 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Day 57: 24 hours, n=32, 36 | 1.4 Milliseconds | Standard Deviation 13.22 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QTc interval, Week 10, n=6, 9 | -10.3 Milliseconds | Standard Deviation 11.74 |
| Recombinant Human Erythropoietin | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | QRS duration, Week 10, n=39, 40 | 0.7 Milliseconds | Standard Deviation 18.38 |
Other Pre-specified
Change From Baseline Values for Hematology Parameter: Ery. MCV
Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Hematology Parameter: Ery. MCV | Day 29, n=37, 38 | 1.2 Femtoliters | Standard Deviation 2.47 |
| Daprodustat | Change From Baseline Values for Hematology Parameter: Ery. MCV | Day 57, n=31, 34 | 1.5 Femtoliters | Standard Deviation 3.5 |
| Daprodustat | Change From Baseline Values for Hematology Parameter: Ery. MCV | Week 10, n=39, 37 | 2.7 Femtoliters | Standard Deviation 4.8 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Ery. MCV | Day 29, n=37, 38 | 1.8 Femtoliters | Standard Deviation 3.32 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Ery. MCV | Day 57, n=31, 34 | 2.9 Femtoliters | Standard Deviation 3.54 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Ery. MCV | Week 10, n=39, 37 | 1.4 Femtoliters | Standard Deviation 3.62 |
Other Pre-specified
Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width
Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Day 29, n=37, 38 | 0.38 Percentage of width | Standard Deviation 1.197 |
| Daprodustat | Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Day 57, n=31, 34 | 0.12 Percentage of width | Standard Deviation 1.262 |
| Daprodustat | Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Week 10, n=39, 37 | 0.35 Percentage of width | Standard Deviation 1.998 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Day 29, n=37, 38 | 1.09 Percentage of width | Standard Deviation 1.435 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Day 57, n=31, 34 | 0.85 Percentage of width | Standard Deviation 1.609 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Week 10, n=39, 37 | 0.59 Percentage of width | Standard Deviation 1.65 |
Other Pre-specified
Change From Baseline Values for Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Hematology Parameter: Hematocrit | Week 10, n=39, 37 | -0.0096 Proportion of red blood cells in blood | Standard Deviation 0.04571 |
| Daprodustat | Change From Baseline Values for Hematology Parameter: Hematocrit | Day 29, n=37, 38 | -0.0131 Proportion of red blood cells in blood | Standard Deviation 0.03062 |
| Daprodustat | Change From Baseline Values for Hematology Parameter: Hematocrit | Day 57, n=31, 34 | -0.0016 Proportion of red blood cells in blood | Standard Deviation 0.03717 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Hematocrit | Week 10, n=39, 37 | -0.0054 Proportion of red blood cells in blood | Standard Deviation 0.04944 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Hematocrit | Day 29, n=37, 38 | -0.0136 Proportion of red blood cells in blood | Standard Deviation 0.02614 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameter: Hematocrit | Day 57, n=31, 34 | 0.0131 Proportion of red blood cells in blood | Standard Deviation 0.03609 |
Other Pre-specified
Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 29, n=37, 37 | 0.071 10^9 cells per liter | Standard Deviation 1.1706 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 29, n=37, 37 | 0.095 10^9 cells per liter | Standard Deviation 0.3613 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 57, n=30, 33 | 0.081 10^9 cells per liter | Standard Deviation 1.2291 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Week 10, n=39, 36 | -0.004 10^9 cells per liter | Standard Deviation 0.0349 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Week 10, n=39, 36 | 0.218 10^9 cells per liter | Standard Deviation 1.3096 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 57, n=30, 33 | -0.090 10^9 cells per liter | Standard Deviation 0.3036 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 29, n=37, 37 | 0.6 10^9 cells per liter | Standard Deviation 31.12 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 57, n=30, 33 | 0.016 10^9 cells per liter | Standard Deviation 0.1513 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 57, n=30, 33 | 13.9 10^9 cells per liter | Standard Deviation 47.04 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 29, n=37, 37 | 0.033 10^9 cells per liter | Standard Deviation 0.16 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Week 10, n=39, 37 | 20.6 10^9 cells per liter | Standard Deviation 36.08 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Week 10, n=39, 36 | 0.103 10^9 cells per liter | Standard Deviation 0.3893 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 29, n=37, 37 | 0.23 10^9 cells per liter | Standard Deviation 1.296 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 57, n=30, 33 | 0.024 10^9 cells per liter | Standard Deviation 0.1621 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 57, n=30, 33 | 0.02 10^9 cells per liter | Standard Deviation 1.456 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Week 10, n=39, 36 | 0.042 10^9 cells per liter | Standard Deviation 0.1435 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Week 10, n=39, 36 | 0.42 10^9 cells per liter | Standard Deviation 1.442 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Week 10, n=39, 36 | 0.070 10^9 cells per liter | Standard Deviation 0.1398 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 29, n=37, 37 | -0.007 10^9 cells per liter | Standard Deviation 0.0317 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 29, n=37, 37 | 0.040 10^9 cells per liter | Standard Deviation 0.1717 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 57, n=30, 33 | -0.002 10^9 cells per liter | Standard Deviation 0.0331 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Week 10, n=39, 36 | 0.181 10^9 cells per liter | Standard Deviation 0.9586 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Week 10, n=39, 36 | 0.078 10^9 cells per liter | Standard Deviation 0.466 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Week 10, n=39, 36 | 0.009 10^9 cells per liter | Standard Deviation 0.0323 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 29, n=37, 37 | -0.039 10^9 cells per liter | Standard Deviation 0.1728 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 57, n=30, 33 | -0.038 10^9 cells per liter | Standard Deviation 0.1202 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Week 10, n=39, 36 | -0.036 10^9 cells per liter | Standard Deviation 0.1702 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 29, n=37, 37 | 0.102 10^9 cells per liter | Standard Deviation 0.4154 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 57, n=30, 33 | -0.099 10^9 cells per liter | Standard Deviation 0.3277 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 29, n=37, 37 | 0.035 10^9 cells per liter | Standard Deviation 0.1266 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 57, n=30, 33 | 0.025 10^9 cells per liter | Standard Deviation 0.1543 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Week 10, n=39, 36 | 0.053 10^9 cells per liter | Standard Deviation 0.1248 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 29, n=37, 37 | 0.061 10^9 cells per liter | Standard Deviation 1.3382 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 57, n=30, 33 | 0.325 10^9 cells per liter | Standard Deviation 1.1549 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 57, n=30, 33 | 0.004 10^9 cells per liter | Standard Deviation 0.0335 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 29, n=37, 37 | 22.7 10^9 cells per liter | Standard Deviation 52.46 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 57, n=30, 33 | 16.4 10^9 cells per liter | Standard Deviation 39.51 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Week 10, n=39, 37 | 26.3 10^9 cells per liter | Standard Deviation 41.87 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 29, n=37, 37 | 0.17 10^9 cells per liter | Standard Deviation 1.555 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 57, n=30, 33 | 0.21 10^9 cells per liter | Standard Deviation 1.231 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Week 10, n=39, 36 | 0.28 10^9 cells per liter | Standard Deviation 1.22 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 29, n=37, 37 | 0.010 10^9 cells per liter | Standard Deviation 0.0329 |
Other Pre-specified
Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr
Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | ery. MCH, Day 29, n=37, 38 | 0.39 Picograms | Standard Deviation 0.676 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | ery. MCH, Day 57, n=31, 34 | 0.70 Picograms | Standard Deviation 1.161 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | ery. MCH, Week 10, n=39, 37 | 0.78 Picograms | Standard Deviation 1.249 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | CHr, Day 29, n=36, 40 | -0.23 Picograms | Standard Deviation 0.937 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | CHr, Day 57, n=32, 36 | -0.12 Picograms | Standard Deviation 1.067 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | CHr, Week 10, n=39, 39 | -0.29 Picograms | Standard Deviation 1.696 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | CHr, Day 57, n=32, 36 | -0.09 Picograms | Standard Deviation 1.617 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | ery. MCH, Day 29, n=37, 38 | 0.40 Picograms | Standard Deviation 0.672 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | CHr, Day 29, n=36, 40 | 0.20 Picograms | Standard Deviation 1.06 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | ery. MCH, Day 57, n=31, 34 | 0.49 Picograms | Standard Deviation 0.871 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | CHr, Week 10, n=39, 39 | -0.03 Picograms | Standard Deviation 1.478 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | ery. MCH, Week 10, n=39, 37 | 0.38 Picograms | Standard Deviation 1 |
Other Pre-specified
Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes
Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 29, n=37, 38 | -0.17 10^12 cells per liter | Standard Deviation 0.331 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 57, n=31, 34 | -0.06 10^12 cells per liter | Standard Deviation 0.41 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Week 10, n=39, 37 | -0.18 10^12 cells per liter | Standard Deviation 0.488 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 29, n=37, 38 | 0.0156 10^12 cells per liter | Standard Deviation 0.01432 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 57, n=31, 34 | 0.0169 10^12 cells per liter | Standard Deviation 0.01709 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Week 10, n=39, 37 | 0.0314 10^12 cells per liter | Standard Deviation 0.04385 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 57, n=31, 34 | 0.0204 10^12 cells per liter | Standard Deviation 0.02182 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 29, n=37, 38 | -0.20 10^12 cells per liter | Standard Deviation 0.273 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day 29, n=37, 38 | 0.0315 10^12 cells per liter | Standard Deviation 0.03821 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day 57, n=31, 34 | 0.04 10^12 cells per liter | Standard Deviation 0.307 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Week 10, n=39, 37 | 0.0159 10^12 cells per liter | Standard Deviation 0.02321 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Week 10, n=39, 37 | -0.11 10^12 cells per liter | Standard Deviation 0.497 |
Other Pre-specified
Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC
Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Days 29, 57 and Week 10
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Hemoglobin, Day 29, n=37, 38 | -4.1 Grams per liter | Standard Deviation 9.35 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Hemoglobin, Day 57, n=31, 34 | 0.5 Grams per liter | Standard Deviation 10.6 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Hemoglobin, Week 10, n=39, 37 | -3.2 Grams per liter | Standard Deviation 14.35 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | ery.MCHC, Day 29, n=37, 38 | 0.3 Grams per liter | Standard Deviation 8.41 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | ery.MCHC, Day 57, n=31, 34 | 2.3 Grams per liter | Standard Deviation 8.83 |
| Daprodustat | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | ery.MCHC, Week 10, n=39, 37 | -0.6 Grams per liter | Standard Deviation 9.37 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | ery.MCHC, Day 57, n=31, 34 | -4.4 Grams per liter | Standard Deviation 14.46 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Hemoglobin, Day 29, n=37, 38 | -5.1 Grams per liter | Standard Deviation 8.21 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | ery.MCHC, Day 29, n=37, 38 | -2.0 Grams per liter | Standard Deviation 10.38 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Hemoglobin, Day 57, n=31, 34 | 2.5 Grams per liter | Standard Deviation 8.54 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | ery.MCHC, Week 10, n=39, 37 | -0.8 Grams per liter | Standard Deviation 11.2 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Hemoglobin, Week 10, n=39, 37 | -1.8 Grams per liter | Standard Deviation 14.46 |
Other Pre-specified
Change From Baseline Values for Pulse Rate
Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 57: post dialysis, n=32, 36 | 0.53 Beats per minute | Standard Deviation 9.308 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 29: pre-dialysis, n=38, 40 | 0.87 Beats per minute | Standard Deviation 9.393 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 57: 3 hours, n=32, 36 | -1.19 Beats per minute | Standard Deviation 11.998 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 1: 3 hours, n=44, 43 | 0.61 Beats per minute | Standard Deviation 7.735 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 57: 12 hours, n=32, 36 | -1.59 Beats per minute | Standard Deviation 12.104 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 29: post dialysis, n=38, 40 | 1.95 Beats per minute | Standard Deviation 11.203 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 57: 24 hours, n=32, 36 | -0.94 Beats per minute | Standard Deviation 11.435 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 1: 24 hours, n=41, 40 | 1.39 Beats per minute | Standard Deviation 10.954 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Week 10: pre-dialysis, n=42, 42 | 1.33 Beats per minute | Standard Deviation 10.195 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day 57: pre-dialysis, n=32, 36 | 2.50 Beats per minute | Standard Deviation 10.522 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Week 10: post dialysis, n=41, 42 | -0.54 Beats per minute | Standard Deviation 9.344 |
| Daprodustat | Change From Baseline Values for Pulse Rate | Day1: 12 hours, n=44, 43 | 0.09 Beats per minute | Standard Deviation 8.232 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Week 10: post dialysis, n=41, 42 | -1.74 Beats per minute | Standard Deviation 11.232 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 1: 24 hours, n=41, 40 | -0.35 Beats per minute | Standard Deviation 11.005 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 1: 3 hours, n=44, 43 | 0.02 Beats per minute | Standard Deviation 10.859 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 29: pre-dialysis, n=38, 40 | 0.03 Beats per minute | Standard Deviation 10.85 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 29: post dialysis, n=38, 40 | 0.15 Beats per minute | Standard Deviation 12.593 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 57: pre-dialysis, n=32, 36 | 2.14 Beats per minute | Standard Deviation 10.805 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 57: post dialysis, n=32, 36 | 0.72 Beats per minute | Standard Deviation 12.523 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 57: 3 hours, n=32, 36 | 0.22 Beats per minute | Standard Deviation 12.547 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 57: 12 hours, n=32, 36 | 0.08 Beats per minute | Standard Deviation 10.811 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day 57: 24 hours, n=32, 36 | 0.33 Beats per minute | Standard Deviation 10.368 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Week 10: pre-dialysis, n=42, 42 | -0.48 Beats per minute | Standard Deviation 13.457 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Pulse Rate | Day1: 12 hours, n=44, 43 | -3.53 Beats per minute | Standard Deviation 12.473 |
Other Pre-specified
Change From Baseline Values for Temperature
Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Temperature | Day 1: 3 hours, n=44, 43 | -0.027 Degrees celsius | Standard Deviation 0.3744 |
| Daprodustat | Change From Baseline Values for Temperature | Day1: 12 hours, n=44, 43 | 0.016 Degrees celsius | Standard Deviation 0.4011 |
| Daprodustat | Change From Baseline Values for Temperature | Day 1: 24 hours, n=41, 40 | 0.015 Degrees celsius | Standard Deviation 0.3712 |
| Daprodustat | Change From Baseline Values for Temperature | Day 29: pre-dialysis, n=38, 40 | -0.089 Degrees celsius | Standard Deviation 0.5451 |
| Daprodustat | Change From Baseline Values for Temperature | Day 29: post dialysis, n=38, 40 | -0.163 Degrees celsius | Standard Deviation 0.479 |
| Daprodustat | Change From Baseline Values for Temperature | Day 57: pre-dialysis, n=32, 36 | -0.003 Degrees celsius | Standard Deviation 0.4447 |
| Daprodustat | Change From Baseline Values for Temperature | Day 57: post dialysis, n=32, 36 | -0.038 Degrees celsius | Standard Deviation 0.3774 |
| Daprodustat | Change From Baseline Values for Temperature | Day 57: 3 hours, n=32, 36 | 0.000 Degrees celsius | Standard Deviation 0.4048 |
| Daprodustat | Change From Baseline Values for Temperature | Day 57: 12 hours, n=32, 36 | 0.103 Degrees celsius | Standard Deviation 0.5196 |
| Daprodustat | Change From Baseline Values for Temperature | Day 57: 24 hours, n=32, 36 | 0.025 Degrees celsius | Standard Deviation 0.4501 |
| Daprodustat | Change From Baseline Values for Temperature | Week 10: pre-dialysis, n=42, 42 | -0.055 Degrees celsius | Standard Deviation 0.484 |
| Daprodustat | Change From Baseline Values for Temperature | Week 10: post dialysis, n=41, 42 | -0.002 Degrees celsius | Standard Deviation 0.527 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Week 10: pre-dialysis, n=42, 42 | -0.062 Degrees celsius | Standard Deviation 0.4328 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 1: 3 hours, n=44, 43 | -0.067 Degrees celsius | Standard Deviation 0.322 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 57: post dialysis, n=32, 36 | -0.053 Degrees celsius | Standard Deviation 0.3247 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day1: 12 hours, n=44, 43 | 0.065 Degrees celsius | Standard Deviation 0.3981 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 57: 24 hours, n=32, 36 | 0.075 Degrees celsius | Standard Deviation 0.3557 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 1: 24 hours, n=41, 40 | -0.050 Degrees celsius | Standard Deviation 0.3359 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 57: 3 hours, n=32, 36 | 0.067 Degrees celsius | Standard Deviation 0.4697 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 29: pre-dialysis, n=38, 40 | -0.033 Degrees celsius | Standard Deviation 0.3731 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Week 10: post dialysis, n=41, 42 | 0.005 Degrees celsius | Standard Deviation 0.4311 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 29: post dialysis, n=38, 40 | -0.070 Degrees celsius | Standard Deviation 0.4027 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 57: 12 hours, n=32, 36 | -0.017 Degrees celsius | Standard Deviation 0.3085 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Temperature | Day 57: pre-dialysis, n=32, 36 | -0.028 Degrees celsius | Standard Deviation 0.4158 |
Other Pre-specified
Change From Baseline Values for Vital Signs: SBP and DBP
Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis
Population: Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 1: 3 hours, n=44, 43 | 5.34 Millimeters of mercury | Standard Deviation 20.307 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day1: 12 hours, n=44, 43 | 6.75 Millimeters of mercury | Standard Deviation 25.642 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 1: 24 hours, n=41, 40 | 3.90 Millimeters of mercury | Standard Deviation 21.846 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 29: pre-dialysis, n=38, 40 | 8.24 Millimeters of mercury | Standard Deviation 27.069 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 29: post dialysis, n=38, 40 | -3.84 Millimeters of mercury | Standard Deviation 20.676 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: pre-dialysis, n=32, 36 | 6.63 Millimeters of mercury | Standard Deviation 25.125 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: post dialysis, n=32, 36 | -0.47 Millimeters of mercury | Standard Deviation 22.747 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: 3 hours, n=32, 36 | 4.81 Millimeters of mercury | Standard Deviation 22.938 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: 12 hours, n=32, 36 | -5.66 Millimeters of mercury | Standard Deviation 25.575 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: 24 hours, n=32, 36 | 7.66 Millimeters of mercury | Standard Deviation 21.919 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Week 10: pre-dialysis, n=42, 42 | 7.36 Millimeters of mercury | Standard Deviation 21.412 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Week 10: post dialysis, n=41, 42 | 2.73 Millimeters of mercury | Standard Deviation 19.005 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 1: 3 hours, n=44, 43 | 5.07 Millimeters of mercury | Standard Deviation 12.617 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day1: 12 hours, n=44, 43 | 7.27 Millimeters of mercury | Standard Deviation 13.588 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 1: 24 hours, n=41, 40 | 4.07 Millimeters of mercury | Standard Deviation 13.129 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 29: pre-dialysis, n=38, 40 | 2.63 Millimeters of mercury | Standard Deviation 14.749 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 29: post dialysis, n=38, 40 | 0.18 Millimeters of mercury | Standard Deviation 13.854 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: pre-dialysis, n=32, 36 | 2.94 Millimeters of mercury | Standard Deviation 13.457 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: post dialysis, n=32, 36 | 1.72 Millimeters of mercury | Standard Deviation 11.277 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: 3 hours, n=32, 36 | 2.69 Millimeters of mercury | Standard Deviation 17.087 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: 12 hours, n=32, 36 | -2.38 Millimeters of mercury | Standard Deviation 13.76 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: 24 hours, n=32, 36 | 6.69 Millimeters of mercury | Standard Deviation 15.995 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Week 10: pre-dialysis, n=42, 42 | 3.71 Millimeters of mercury | Standard Deviation 13.328 |
| Daprodustat | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Week 10: post dialysis, n=41, 42 | 1.00 Millimeters of mercury | Standard Deviation 10.151 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Week 10: pre-dialysis, n=42, 42 | 3.50 Millimeters of mercury | Standard Deviation 12.975 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 1: 3 hours, n=44, 43 | 7.05 Millimeters of mercury | Standard Deviation 18.639 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 1: 3 hours, n=44, 43 | 3.49 Millimeters of mercury | Standard Deviation 13.17 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day1: 12 hours, n=44, 43 | 6.56 Millimeters of mercury | Standard Deviation 17.633 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: post dialysis, n=32, 36 | 1.72 Millimeters of mercury | Standard Deviation 12.23 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 1: 24 hours, n=41, 40 | 6.23 Millimeters of mercury | Standard Deviation 18.15 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day1: 12 hours, n=44, 43 | 5.14 Millimeters of mercury | Standard Deviation 13.105 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: 12 hours, n=32, 36 | 9.97 Millimeters of mercury | Standard Deviation 20.52 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 29: pre-dialysis, n=38, 40 | 12.00 Millimeters of mercury | Standard Deviation 25.314 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: 24 hours, n=32, 36 | 3.97 Millimeters of mercury | Standard Deviation 13.729 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 29: post dialysis, n=38, 40 | 5.83 Millimeters of mercury | Standard Deviation 21.882 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 1: 24 hours, n=41, 40 | 4.18 Millimeters of mercury | Standard Deviation 11.569 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: pre-dialysis, n=32, 36 | 16.03 Millimeters of mercury | Standard Deviation 20.492 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: 3 hours, n=32, 36 | 4.89 Millimeters of mercury | Standard Deviation 14.54 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: post dialysis, n=32, 36 | 6.14 Millimeters of mercury | Standard Deviation 20.699 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 29: pre-dialysis, n=38, 40 | 5.88 Millimeters of mercury | Standard Deviation 14.65 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: 3 hours, n=32, 36 | 12.56 Millimeters of mercury | Standard Deviation 20.832 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Week 10: post dialysis, n=41, 42 | -2.81 Millimeters of mercury | Standard Deviation 12.934 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 29: post dialysis, n=38, 40 | 1.23 Millimeters of mercury | Standard Deviation 12.259 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Day 57: 24 hours, n=32, 36 | 9.33 Millimeters of mercury | Standard Deviation 22.08 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: 12 hours, n=32, 36 | 5.11 Millimeters of mercury | Standard Deviation 14.186 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Week 10: pre-dialysis, n=42, 42 | 10.48 Millimeters of mercury | Standard Deviation 19.261 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | DBP, Day 57: pre-dialysis, n=32, 36 | 5.86 Millimeters of mercury | Standard Deviation 13.316 |
| Recombinant Human Erythropoietin | Change From Baseline Values for Vital Signs: SBP and DBP | SBP, Week 10: post dialysis, n=41, 42 | 0.10 Millimeters of mercury | Standard Deviation 23.472 |
Other Pre-specified
Number of Participants Who Discontinued the Study Treatment
Number of participants who discontinued the study treatment due to any reason are presented. The reasons for discontinuation included adverse events, protocol specified withdrawal criteria met, physician decision and withdrawal by participant.
Time frame: Up to Week 10
Population: ITT Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daprodustat | Number of Participants Who Discontinued the Study Treatment | Withdrawal by participant | 3 Participants |
| Daprodustat | Number of Participants Who Discontinued the Study Treatment | Adverse event | 2 Participants |
| Daprodustat | Number of Participants Who Discontinued the Study Treatment | Physician decision | 1 Participants |
| Daprodustat | Number of Participants Who Discontinued the Study Treatment | Protocol-specified withdrawal criteria met | 7 Participants |
| Recombinant Human Erythropoietin | Number of Participants Who Discontinued the Study Treatment | Physician decision | 1 Participants |
| Recombinant Human Erythropoietin | Number of Participants Who Discontinued the Study Treatment | Withdrawal by participant | 0 Participants |
| Recombinant Human Erythropoietin | Number of Participants Who Discontinued the Study Treatment | Adverse event | 2 Participants |
| Recombinant Human Erythropoietin | Number of Participants Who Discontinued the Study Treatment | Protocol-specified withdrawal criteria met | 4 Participants |
Other Pre-specified
Number of Participants With Any Serious Adverse Events (SAEs)
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.
Time frame: Up to Week 10
Population: Safety Population comprises of all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat | Number of Participants With Any Serious Adverse Events (SAEs) | 10 Participants |
| Recombinant Human Erythropoietin | Number of Participants With Any Serious Adverse Events (SAEs) | 5 Participants |
Other Pre-specified
Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs)
An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Number of participants with treatment emergent common (\>=2% non-SAEs in each arm) non-SAEs has been presented.
Time frame: Up to Week 8
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat | Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs) | 10 Participants |
| Recombinant Human Erythropoietin | Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs) | 4 Participants |