Anaemia
Conditions
Keywords
Daprodustat, recombinant human erythropoietin, darbepoetin, anemia, chronic kidney disease, dialysis, ESRD
Brief summary
The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
Interventions
DRUGDaprodustat
Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.
DRUGDarbepoetin alfa
Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.
DRUGIron therapy
Iron therapy will be administered if ferritin is \<=100 ng/mL and/or TSAT is \<=20%.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 99 years of age inclusive. * Planning to start chronic dialysis within the next 6 weeks (from the date of the screening visit) OR have started and received dialysis (as specified below) for end-stage renal disease for a maximum of \<=90 days immediately prior to randomization and is not expected to stop dialysis during the duration of the trial: HD \>=2 times per week or PD \>=4 times per week including incremental schedule; subjects on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) are eligible. * Hemoglobin concentration as measured by HemoCue (range inclusive): 8 to 10.5 g/dL (5-6.5 millimoles per liter \[mmol/L\]) at screening and 8-11.0 g/dL (5 to 6.8 mmol/L) at randomization. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion criteria
* Planned living-related or living-unrelated kidney transplant during the study. * Ferritin: \<=100 nanograms per milliliter (ng/mL) (\<=100 micrograms per liter \[mcg/L\]) at screening or after IV iron supplementation. * Transferrin saturation (TSAT): \<=20% at screening or after IV iron supplementation. * Vitamin B12 (cobalamin): Below the lower limit of the reference range at screening or after vitamin B12 supplementation. * Folate: \<2.0 ng/mL (\<4.5 nanomoles per liter \[nmol/L\]) at screening. * Aplasias: History of bone marrow aplasia or pure red cell aplasia (PRCA). * Other causes of anemia: Untreated pernicious anemia, thalassemia major, sickle cell disease, or myelodysplastic syndrome. * Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding \<=10 weeks prior to screening through to randomization (Day 1). * Use of any Erythropoiesis-stimulating agent (ESA) treatment within 8 weeks prior to screening except for limited use as part of dialysis initiation. Note : Limited use is defined as no more than 6 weeks of short acting ESA (rhEPO or biosimilars; maximum of 20000 unit total) or long acting ESA (darbepoetin alfa \[maximum of 100 mcg total\] or methoxy polyethylene glycol-epoetin beta \[maximum of 125 mcg total\]) received before or after starting dialysis. * Myocardial infarction or acute coronary syndrome: \<=10 weeks prior to screening through to randomization (Day 1). * Stroke or transient ischemic attack: \<=10 weeks prior to screening through to randomization (Day 1). * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system. * Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of rhEPO. * QT correction using Bazett's (QTcB) (Day 1): QTcB \>500 milliseconds (msec), or QTcB \>530 msec in subjects with bundle branch block. There is no QTc exclusion for subjects with a predominantly ventricular paced rhythm. * Liver disease (any one of the following): 1. Alanine transaminase (ALT) \>2 times upper limit of normal (ULN) (screening only). 2. Bilirubin \>1.5 times ULN (screening only) (NOTE: Isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). 3. 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. NOTE: Stable chronic liver disease (including asymptomatic gallstones, chronic hepatitis B or C, or Gilbert's syndrome) are acceptable if subject otherwise meets entry criteria. * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (i.e. Bosniak Category II F, III or IV) \>3 centimeter (cm). The only exception is localized squamous cell or basal cell carcinoma of the skin that has been definitively treated \>=10 weeks prior to screening. * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product or to darbepoetin alfa. * Use of strong Cytochrome P4502C8 (CYP2C8) inhibitors (example gemfibrozil) or strong CYP2C8 inducers (example rifampin/rifampicin). * Use of other investigational agent or device prior to screening through to randomization (Day 1). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half-lives (whichever is longer). * Any prior treatment with daprodustat for treatment duration of \>30 days. * Females only: Subject is pregnant \[as confirmed by a positive serum human chorionic gonadotropin (hCG) test for females of reproductive potential (FRP) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options in the List of Highly Effective Methods for Avoiding Pregnancy. * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (example intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Weeks 28 to 52 | Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL. |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Baseline (Day 1) and Week 52 | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model. |
| Change From Baseline in SBP, DBP, MAP at End of Treatment | Baseline (Day 1) and end of treatment (last on-treatment value until Week 52) | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model. |
| Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | Up to Week 52 | BP exacerbation event is defined (based on post-dialysis BP) as SBP \>=25 millimeter of mercury (mmHg) increased from Baseline or SBP \>=180 mmHg; or DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model. |
| Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | Up to Week 52 | BP exacerbation was defined (based on post-dialysis BP) as: SBP \>=25 mmHg increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented. |
| Change From Baseline in Post-randomization Hgb at Week 52 | Baseline (Day 1) and Week 52 | Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | Weeks 28 to 52 | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. |
| Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | Weeks 28 to 52 | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. |
| Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Up to Week 52 | Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented. |
| Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Baseline (Day 1), Weeks 8, 12, 28 and 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Baseline (Day 1) to Week 52 | Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood \[red blood cells or whole blood\] transfusion date and treatment stop date plus \[+\] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of \[Week 52 visit date, first blood transfusion date and treatment stop date +1\] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis. |
| Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Baseline (Day 1), Weeks 8, 12, 28 and 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Baseline (Day 1), Weeks 28 and 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Baseline (Day 1), Weeks 28 and 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1), Weeks 8, 12, 28 and 52 | The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52 | Baseline (Day 1) and Week 52 | EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date. |
| Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52 | Baseline (Day 1) and Week 52 | The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Baseline (Day 1) and Week 52 | CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed. |
| Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. |
| Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. |
| Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Baseline (Day 1), Weeks 8, 12, 28 and 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
Countries
Argentina, Australia, Canada, Germany, India, Italy, Malaysia, Mexico, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Participant flow
Recruitment details
This was a multicenter study conducted across 14 countries. Participants were randomized to receive either Daprodustat or Darbepoetin alfa.
Pre-assignment details
A total of 312 participants were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Daprodustat Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]). | 157 |
| Darbepoetin Alfa Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). | 155 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Daprodustat | Darbepoetin Alfa | Total |
|---|---|---|---|
| Age, Continuous | 53.7 Years STANDARD_DEVIATION 14.31 | 55.8 Years STANDARD_DEVIATION 15.7 | 54.7 Years STANDARD_DEVIATION 15.03 |
| Race/Ethnicity, Customized American Indian (AI) or Alaskan Native (AN) | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian: Central/South Asian Heritage | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian: East Asian Heritage | 8 Participants | 16 Participants | 24 Participants |
| Race/Ethnicity, Customized Asian: South East Asian Heritage | 11 Participants | 9 Participants | 20 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants | 13 Participants | 29 Participants |
| Race/Ethnicity, Customized Mixed race: AI or AN and White | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White: Arabic/North African Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White: White/Caucasian/European Heritage | 109 Participants | 107 Participants | 216 Participants |
| Sex: Female, Male Female | 61 Participants | 57 Participants | 118 Participants |
| Sex: Female, Male Male | 96 Participants | 98 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 157 | 12 / 155 |
| other Total, other adverse events | 76 / 157 | 74 / 155 |
| serious Total, serious adverse events | 52 / 157 | 51 / 155 |
Outcome results
Primary
Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52)
Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa).
Time frame: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
Population: Intent-to-Treat (ITT) Population comprised all randomized participants (who received a treatment randomization number).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | 1.02 Grams per deciliter | Standard Error 0.086 |
| Darbepoetin Alfa | Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | 1.12 Grams per deciliter | Standard Error 0.085 |
95% CI: [-0.34, 0.14]
Secondary
Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52
Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood \[red blood cells or whole blood\] transfusion date and treatment stop date plus \[+\] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of \[Week 52 visit date, first blood transfusion date and treatment stop date +1\] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis.
Time frame: Baseline (Day 1) to Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | 144.7 Milligram | Standard Error 10.9 |
| Darbepoetin Alfa | Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | 125.3 Milligram | Standard Error 10.97 |
p-value: 0.894995% CI: [-11, 49.9]ANCOVA
Secondary
Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years
BP exacerbation event is defined (based on post-dialysis BP) as SBP \>=25 millimeter of mercury (mmHg) increased from Baseline or SBP \>=180 mmHg; or DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.
Time frame: Up to Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat | Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | 352.50 Events per 100 participant year |
| Darbepoetin Alfa | Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | 350.00 Events per 100 participant year |
p-value: 0.517495% CI: [0.73, 1.39]Negative binomial model
Secondary
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1) and Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Cognitive domain | -4.17 Scores on a scale | Standard Error 1.893 |
| Daprodustat | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Severity-short breath, Resting | -4.16 Scores on a scale | Standard Error 1.869 |
| Daprodustat | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Chest pain/Shortness of breath domain | -1.83 Scores on a scale | Standard Error 1.593 |
| Daprodustat | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Difficulty standing for long time | -2.00 Scores on a scale | Standard Error 2.812 |
| Daprodustat | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Shortness of breath, no activity | -1.90 Scores on a scale | Standard Error 1.861 |
| Daprodustat | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Difficulty sleeping | -5.27 Scores on a scale | Standard Error 2.667 |
| Daprodustat | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Tired/Low energy/Weak domain | -2.36 Scores on a scale | Standard Error 2.007 |
| Darbepoetin Alfa | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Difficulty sleeping | 1.26 Scores on a scale | Standard Error 2.611 |
| Darbepoetin Alfa | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Tired/Low energy/Weak domain | 4.07 Scores on a scale | Standard Error 1.99 |
| Darbepoetin Alfa | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Chest pain/Shortness of breath domain | 2.28 Scores on a scale | Standard Error 1.557 |
| Darbepoetin Alfa | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Cognitive domain | 2.43 Scores on a scale | Standard Error 1.852 |
| Darbepoetin Alfa | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Shortness of breath, no activity | 1.14 Scores on a scale | Standard Error 1.826 |
| Darbepoetin Alfa | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Severity-short breath, Resting | 0.12 Scores on a scale | Standard Error 1.836 |
| Darbepoetin Alfa | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Difficulty standing for long time | 3.30 Scores on a scale | Standard Error 2.754 |
p-value: 0.958695% CI: [-13.9, 0.86]MMRM
p-value: 0.987595% CI: [-12.05, -0.82]MMRM
p-value: 0.966395% CI: [-8.52, 0.3]MMRM
p-value: 0.99395% CI: [-11.84, -1.35]MMRM
p-value: 0.876595% CI: [-8.19, 2.12]MMRM
p-value: 0.946495% CI: [-9.48, 0.94]MMRM
p-value: 0.910195% CI: [-13.09, 2.47]MMRM
Secondary
Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52
The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1) and Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52 | 3.4 Scores on a scale | Standard Error 3.27 |
| Darbepoetin Alfa | Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52 | 6.8 Scores on a scale | Standard Error 3.28 |
p-value: 0.765195% CI: [-12.7, 5.9]MMRM
Secondary
Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52
EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.
Time frame: Baseline (Day 1) and Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52 | 0.00 Scores on a scale | Standard Error 0.041 |
| Darbepoetin Alfa | Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52 | -0.03 Scores on a scale | Standard Error 0.04 |
p-value: 0.315495% CI: [-0.09, 0.14]MMRM
Secondary
Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 8, n=88,86 | 0.10 Scores on a scale | Standard Error 0.822 |
| Daprodustat | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 12, n=88,88 | 0.08 Scores on a scale | Standard Error 0.813 |
| Daprodustat | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 28, n=80,74 | -0.02 Scores on a scale | Standard Error 0.905 |
| Daprodustat | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 52, n=67,65 | -0.95 Scores on a scale | Standard Error 1.029 |
| Darbepoetin Alfa | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 52, n=67,65 | -0.72 Scores on a scale | Standard Error 1.051 |
| Darbepoetin Alfa | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 8, n=88,86 | 0.76 Scores on a scale | Standard Error 0.839 |
| Darbepoetin Alfa | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 28, n=80,74 | 0.30 Scores on a scale | Standard Error 0.942 |
| Darbepoetin Alfa | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Week 12, n=88,88 | 1.60 Scores on a scale | Standard Error 0.824 |
p-value: 0.714695% CI: [-2.99, 1.66]MMRM
p-value: 0.90595% CI: [-3.82, 0.76]MMRM
p-value: 0.59595% CI: [-2.91, 2.28]MMRM
p-value: 0.561995% CI: [-3.17, 2.7]MMRM
Secondary
Change From Baseline in Patient Global Impression of Severity (PGI-S)
The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 8, n=100,100 | 0.16 Scores on a scale | Standard Error 0.091 |
| Daprodustat | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 28, n=92,85 | 0.09 Scores on a scale | Standard Error 0.086 |
| Daprodustat | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 12, n=100,103 | 0.02 Scores on a scale | Standard Error 0.077 |
| Daprodustat | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 52, n=75,77 | 0.22 Scores on a scale | Standard Error 0.106 |
| Darbepoetin Alfa | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 12, n=100,103 | -0.03 Scores on a scale | Standard Error 0.077 |
| Darbepoetin Alfa | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 8, n=100,100 | -0.11 Scores on a scale | Standard Error 0.092 |
| Darbepoetin Alfa | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 52, n=75,77 | 0.04 Scores on a scale | Standard Error 0.105 |
| Darbepoetin Alfa | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Week 28, n=92,85 | -0.07 Scores on a scale | Standard Error 0.089 |
p-value: 0.98195% CI: [0.02, 0.53]MMRM
p-value: 0.674395% CI: [-0.17, 0.26]MMRM
p-value: 0.899795% CI: [-0.09, 0.4]MMRM
p-value: 0.883595% CI: [-0.12, 0.47]MMRM
Secondary
Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 8, n=88,86 | 0.79 Scores on a scale | Standard Error 0.648 |
| Daprodustat | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 12, n=88,88 | 1.67 Scores on a scale | Standard Error 0.627 |
| Daprodustat | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 28, n=80,74 | 0.94 Scores on a scale | Standard Error 0.697 |
| Daprodustat | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 52, n=67,65 | 0.61 Scores on a scale | Standard Error 0.755 |
| Darbepoetin Alfa | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 52, n=67,65 | 1.93 Scores on a scale | Standard Error 0.774 |
| Darbepoetin Alfa | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 8, n=88,86 | 1.18 Scores on a scale | Standard Error 0.658 |
| Darbepoetin Alfa | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 28, n=80,74 | 0.45 Scores on a scale | Standard Error 0.725 |
| Darbepoetin Alfa | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Week 12, n=88,88 | 0.54 Scores on a scale | Standard Error 0.631 |
p-value: 0.664195% CI: [-2.22, 1.44]MMRM
p-value: 0.10395% CI: [-0.63, 2.89]MMRM
p-value: 0.315795% CI: [-1.51, 2.48]MMRM
p-value: 0.885595% CI: [-3.46, 0.84]MMRM
Secondary
Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1), Weeks 28 and 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 28, n=80,74 | 0.55 Scores on a scale | Standard Error 0.863 |
| Daprodustat | Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 52, n=67,65 | 0.14 Scores on a scale | Standard Error 0.947 |
| Darbepoetin Alfa | Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 28, n=80,74 | 0.83 Scores on a scale | Standard Error 0.898 |
| Darbepoetin Alfa | Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 52, n=67,65 | 1.58 Scores on a scale | Standard Error 0.973 |
p-value: 0.587995% CI: [-2.75, 2.19]MMRM
p-value: 0.852595% CI: [-4.12, 1.26]MMRM
Secondary
Change From Baseline in Post-randomization Hgb at Week 52
Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1) and Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat | Change From Baseline in Post-randomization Hgb at Week 52 | 1.17 Grams per deciliter | Standard Error 0.117 |
| Darbepoetin Alfa | Change From Baseline in Post-randomization Hgb at Week 52 | 1.13 Grams per deciliter | Standard Error 0.115 |
95% CI: [-0.29, 0.36]
Secondary
Change From Baseline in SBP, DBP, MAP at End of Treatment
SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model.
Time frame: Baseline (Day 1) and end of treatment (last on-treatment value until Week 52)
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in SBP, DBP, MAP at End of Treatment | SBP | -3.23 Millimeter of mercury | Standard Error 1.659 |
| Daprodustat | Change From Baseline in SBP, DBP, MAP at End of Treatment | DBP | 0.60 Millimeter of mercury | Standard Error 1.016 |
| Daprodustat | Change From Baseline in SBP, DBP, MAP at End of Treatment | MAP | -0.68 Millimeter of mercury | Standard Error 1.092 |
| Darbepoetin Alfa | Change From Baseline in SBP, DBP, MAP at End of Treatment | SBP | -3.14 Millimeter of mercury | Standard Error 1.664 |
| Darbepoetin Alfa | Change From Baseline in SBP, DBP, MAP at End of Treatment | DBP | -1.39 Millimeter of mercury | Standard Error 1.02 |
| Darbepoetin Alfa | Change From Baseline in SBP, DBP, MAP at End of Treatment | MAP | -1.97 Millimeter of mercury | Standard Error 1.096 |
p-value: 0.48495% CI: [-4.72, 4.53]ANCOVA
p-value: 0.915695% CI: [-0.85, 4.82]ANCOVA
p-value: 0.796695% CI: [-1.76, 4.33]ANCOVA
Secondary
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 28, n=80,74 | 0.63 Scores on a scale | Standard Error 0.693 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 12, n=88,88 | -0.13 Scores on a scale | Standard Error 0.892 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 28, n=80,74 | 1.08 Scores on a scale | Standard Error 0.941 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 52, n=67,65 | -2.00 Scores on a scale | Standard Error 1.084 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 8, n=88,86 | 0.80 Scores on a scale | Standard Error 0.662 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 12, n=88,88 | 0.87 Scores on a scale | Standard Error 0.651 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 8, n=88,86 | -0.41 Scores on a scale | Standard Error 0.833 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 52, n=67,65 | 0.40 Scores on a scale | Standard Error 0.823 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 8, n=88,86 | -0.90 Scores on a scale | Standard Error 0.825 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 12, n=88,88 | 0.01 Scores on a scale | Standard Error 0.707 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 28, n=80,74 | -0.69 Scores on a scale | Standard Error 0.866 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 52, n=67,65 | -0.53 Scores on a scale | Standard Error 0.994 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 8, n=88,86 | 0.83 Scores on a scale | Standard Error 0.88 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 12, n=88,88 | 0.55 Scores on a scale | Standard Error 0.934 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 28, n=80,74 | 0.91 Scores on a scale | Standard Error 0.929 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 52, n=67,65 | -1.60 Scores on a scale | Standard Error 1.193 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 8, n=88,86 | 1.34 Scores on a scale | Standard Error 0.806 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 12, n=88,88 | 2.39 Scores on a scale | Standard Error 0.712 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 28, n=80,74 | 0.62 Scores on a scale | Standard Error 0.799 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 52, n=67,65 | 1.49 Scores on a scale | Standard Error 0.895 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 8, n=88,86 | 0.52 Scores on a scale | Standard Error 0.929 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 12, n=88,88 | 0.98 Scores on a scale | Standard Error 0.774 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 28, n=80,74 | 1.03 Scores on a scale | Standard Error 0.943 |
| Daprodustat | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 52, n=67,65 | 0.39 Scores on a scale | Standard Error 1.085 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 28, n=80,74 | 0.95 Scores on a scale | Standard Error 0.98 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 8, n=88,86 | -0.55 Scores on a scale | Standard Error 0.843 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 8, n=88,86 | 0.50 Scores on a scale | Standard Error 0.896 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 12, n=88,88 | -0.06 Scores on a scale | Standard Error 0.895 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 28, n=80,74 | 1.49 Scores on a scale | Standard Error 0.829 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 28, n=80,74 | -1.26 Scores on a scale | Standard Error 0.976 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 12, n=88,88 | -0.07 Scores on a scale | Standard Error 0.946 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Bodily pain: Week 52, n=67,65 | 0.61 Scores on a scale | Standard Error 1.109 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 12, n=88,88 | 2.15 Scores on a scale | Standard Error 0.783 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 8, n=88,86 | 0.75 Scores on a scale | Standard Error 0.674 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 28, n=80,74 | 0.39 Scores on a scale | Standard Error 0.964 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 12, n=88,88 | 0.59 Scores on a scale | Standard Error 0.658 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 52, n=67,65 | 2.22 Scores on a scale | Standard Error 0.913 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 28, n=80,74 | 0.37 Scores on a scale | Standard Error 0.72 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-emotional: Week 52, n=67,65 | -0.11 Scores on a scale | Standard Error 1.216 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | General health: Week 52, n=67,65 | 0.58 Scores on a scale | Standard Error 0.841 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 52, n=67,65 | -0.33 Scores on a scale | Standard Error 1.105 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 8, n=88,86 | 0.25 Scores on a scale | Standard Error 0.841 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 8, n=88,86 | 2.64 Scores on a scale | Standard Error 0.818 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 12, n=88,88 | 1.42 Scores on a scale | Standard Error 0.712 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Social functioning: Week 8, n=88,86 | 1.55 Scores on a scale | Standard Error 0.947 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 28, n=80,74 | -0.21 Scores on a scale | Standard Error 0.902 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Role-physical: Week 12, n=88,88 | 1.69 Scores on a scale | Standard Error 0.716 |
| Darbepoetin Alfa | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Mental health: Week 52, n=67,65 | -0.27 Scores on a scale | Standard Error 1.013 |
p-value: 0.452395% CI: [-2.21, 2.49]MMRM
p-value: 0.522295% CI: [-2.57, 2.43]MMRM
p-value: 0.04495% CI: [-0.35, 5.02]MMRM
p-value: 0.952395% CI: [-5.68, 0.46]MMRM
p-value: 0.481195% CI: [-1.82, 1.91]MMRM
p-value: 0.383495% CI: [-1.56, 2.11]MMRM
p-value: 0.398395% CI: [-1.72, 2.24]MMRM
p-value: 0.561795% CI: [-2.51, 2.15]MMRM
p-value: 0.833695% CI: [-3.48, 1.18]MMRM
p-value: 0.918895% CI: [-3.4, 0.57]MMRM
p-value: 0.649595% CI: [-2.96, 1.99]MMRM
p-value: 0.573795% CI: [-3.09, 2.56]MMRM
p-value: 0.396395% CI: [-2.15, 2.82]MMRM
p-value: 0.32295% CI: [-2.01, 3.25]MMRM
p-value: 0.348595% CI: [-2.13, 3.18]MMRM
p-value: 0.806495% CI: [-4.87, 1.9]MMRM
p-value: 0.868795% CI: [-3.57, 0.98]MMRM
p-value: 0.243595% CI: [-1.29, 2.7]MMRM
p-value: 0.774795% CI: [-3.15, 1.41]MMRM
p-value: 0.714195% CI: [-3.26, 1.81]MMRM
p-value: 0.780395% CI: [-3.65, 1.59]MMRM
p-value: 0.855695% CI: [-3.35, 1]MMRM
p-value: 0.476395% CI: [-2.61, 2.77]MMRM
p-value: 0.320895% CI: [-2.35, 3.8]MMRM
Secondary
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52
SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model.
Time frame: Baseline (Day 1) and Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | SBP | -3.57 Millimeter of mercury | Standard Error 2.063 |
| Daprodustat | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | DBP | 0.21 Millimeter of mercury | Standard Error 1.216 |
| Daprodustat | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | MAP | -0.95 Millimeter of mercury | Standard Error 1.364 |
| Darbepoetin Alfa | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | SBP | -6.80 Millimeter of mercury | Standard Error 2.931 |
| Darbepoetin Alfa | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | DBP | -4.01 Millimeter of mercury | Standard Error 1.65 |
| Darbepoetin Alfa | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | MAP | -5.05 Millimeter of mercury | Standard Error 1.894 |
p-value: 0.816895% CI: [-3.82, 10.27]Mixed model repeated measures (MMRM)
p-value: 0.979395% CI: [0.17, 8.26]MMRM
p-value: 0.959795% CI: [-0.51, 8.7]MMRM
Secondary
Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Time frame: Baseline (Day 1), Weeks 28 and 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 28, n=80,74 | -0.08 Scores on a scale | Standard Error 0.866 |
| Daprodustat | Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 52, n=67,65 | 0.16 Scores on a scale | Standard Error 0.907 |
| Darbepoetin Alfa | Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 28, n=80,74 | 0.95 Scores on a scale | Standard Error 0.902 |
| Darbepoetin Alfa | Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Week 52, n=67,65 | 1.61 Scores on a scale | Standard Error 0.925 |
p-value: 0.79195% CI: [-3.5, 1.46]MMRM
p-value: 0.864895% CI: [-4.03, 1.14]MMRM
Secondary
Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.
Time frame: Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 2.160 Nanogram per milliliter | Standard Deviation 1.2596 |
| Daprodustat | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 2.283 Nanogram per milliliter | Standard Deviation 1.821 |
| Daprodustat | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 2.477 Nanogram per milliliter | Standard Deviation 1.3625 |
| Daprodustat | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 21.74 Nanogram per milliliter | Standard Deviation 10.998 |
| Darbepoetin Alfa | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 32.29 Nanogram per milliliter | Standard Deviation 40.166 |
| Darbepoetin Alfa | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 4.139 Nanogram per milliliter | Standard Deviation 3.3561 |
| Darbepoetin Alfa | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 5.212 Nanogram per milliliter | Standard Deviation 4.5562 |
| Darbepoetin Alfa | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 3.565 Nanogram per milliliter | Standard Deviation 2.6091 |
| Daprodustat 4 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 7.075 Nanogram per milliliter | Standard Deviation 7.1313 |
| Daprodustat 4 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 5.780 Nanogram per milliliter | Standard Deviation 6.284 |
| Daprodustat 4 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 5.328 Nanogram per milliliter | Standard Deviation 6.9034 |
| Daprodustat 4 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 76.92 Nanogram per milliliter | Standard Deviation 81.867 |
| Daprodustat 6 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 11.60 Nanogram per milliliter | Standard Deviation 6.8731 |
| Daprodustat 6 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 100.2 Nanogram per milliliter | Standard Deviation 74.086 |
| Daprodustat 6 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 7.836 Nanogram per milliliter | Standard Deviation 6.6199 |
| Daprodustat 6 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 10.36 Nanogram per milliliter | Standard Deviation 6.3377 |
| Daprodustat 8 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 32.00 Nanogram per milliliter | — |
| Daprodustat 8 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 10.10 Nanogram per milliliter | — |
| Daprodustat 8 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 5.760 Nanogram per milliliter | — |
| Daprodustat 8 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 6.090 Nanogram per milliliter | — |
| Daprodustat 10 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 16.60 Nanogram per milliliter | — |
| Daprodustat 10 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 145.0 Nanogram per milliliter | — |
| Daprodustat 10 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 22.00 Nanogram per milliliter | — |
| Daprodustat 10 mg | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 10.20 Nanogram per milliliter | — |
Secondary
Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)
Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.
Time frame: Weeks 28 to 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat | Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | 86 Participants |
| Darbepoetin Alfa | Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | 87 Participants |
p-value: 0.541195% CI: [-12.2, 10.7]Cochran-Mantel-Haenszel
Secondary
Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria
Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.
Time frame: Up to Week 52
Population: ITT Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat | Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | 5 Participants |
| Darbepoetin Alfa | Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | 5 Participants |
p-value: 0.534895% CI: [0.31, 3.66]Wald test
Secondary
Number of Participants With at Least One Blood Pressure Exacerbation Event During Study
BP exacerbation was defined (based on post-dialysis BP) as: SBP \>=25 mmHg increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented.
Time frame: Up to Week 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat | Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | 91 Participants |
| Darbepoetin Alfa | Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | 100 Participants |
Secondary
Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.
Time frame: Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 2.118 Nanogram per milliliter | Standard Deviation 5.003 |
| Daprodustat | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 0.7106 Nanogram per milliliter | Standard Deviation 0.64028 |
| Daprodustat | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 1.270 Nanogram per milliliter | Standard Deviation 0.96071 |
| Daprodustat | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 1.642 Nanogram per milliliter | Standard Deviation 1.4836 |
| Darbepoetin Alfa | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 3.508 Nanogram per milliliter | Standard Deviation 4.2066 |
| Darbepoetin Alfa | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 2.124 Nanogram per milliliter | Standard Deviation 2.8721 |
| Darbepoetin Alfa | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 1.015 Nanogram per milliliter | Standard Deviation 3.1451 |
| Darbepoetin Alfa | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 2.729 Nanogram per milliliter | Standard Deviation 1.8934 |
| Daprodustat 4 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 3.750 Nanogram per milliliter | Standard Deviation 3.8006 |
| Daprodustat 4 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 3.879 Nanogram per milliliter | Standard Deviation 3.4207 |
| Daprodustat 4 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 2.087 Nanogram per milliliter | Standard Deviation 2.1371 |
| Daprodustat 4 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 0.5787 Nanogram per milliliter | Standard Deviation 1.5718 |
| Daprodustat 6 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 2.867 Nanogram per milliliter | Standard Deviation 6.6142 |
| Daprodustat 6 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 5.111 Nanogram per milliliter | Standard Deviation 4.0632 |
| Daprodustat 6 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 3.560 Nanogram per milliliter | Standard Deviation 4.2255 |
| Daprodustat 6 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 5.921 Nanogram per milliliter | Standard Deviation 5.8981 |
| Daprodustat 8 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 8.710 Nanogram per milliliter | — |
| Daprodustat 8 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 5.660 Nanogram per milliliter | — |
| Daprodustat 8 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 4.450 Nanogram per milliliter | — |
| Daprodustat 8 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 0.1030 Nanogram per milliliter | — |
| Daprodustat 10 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220 | 6.560 Nanogram per milliliter | — |
| Daprodustat 10 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104 | 9.500 Nanogram per milliliter | — |
| Daprodustat 10 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401 | 7.760 Nanogram per milliliter | — |
| Daprodustat 10 mg | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat | 0.1090 Nanogram per milliliter | — |
Secondary
Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis
Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.
Time frame: Weeks 28 to 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | 57.0 Percentage of days |
| Darbepoetin Alfa | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | 54.7 Percentage of days |
95% CI: [-4.45, 11.27]
Secondary
Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis
Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.
Time frame: Weeks 28 to 52
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | 57.0 Percentage of days |
| Darbepoetin Alfa | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | 54.7 Percentage of days |
p-value: 0.153895% CI: [0.46, 0.61]van Elteren test
Secondary
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed.
Time frame: Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 1.270 Nanogram per milliliter | Standard Deviation 0.96071 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0 | 1.911 Nanogram per milliliter | Standard Deviation 1.2274 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0 | 1.123 Nanogram per milliliter | Standard Deviation 0.7692 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0 | 1.364 Nanogram per milliliter | Standard Deviation 0.96292 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0 | 1.745 Nanogram per milliliter | Standard Deviation 1.316 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 0.5 hour, n=19,26,20,18,0,1,0,0,0 | 5.675 Nanogram per milliliter | Standard Deviation 8.4998 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 2.118 Nanogram per milliliter | Standard Deviation 5.003 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0 | 1.399 Nanogram per milliliter | Standard Deviation 1.4595 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0 | 12.34 Nanogram per milliliter | Standard Deviation 13.435 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 1.427 Nanogram per milliliter | Standard Deviation 1.287 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0 | 12.74 Nanogram per milliliter | Standard Deviation 9.9019 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 1.642 Nanogram per milliliter | Standard Deviation 1.4836 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0 | 2.190 Nanogram per milliliter | Standard Deviation 1.3898 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0 | 7.719 Nanogram per milliliter | Standard Deviation 5.9144 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0 | 1.847 Nanogram per milliliter | Standard Deviation 1.7376 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0 | 1.966 Nanogram per milliliter | Standard Deviation 1.344 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 0.7106 Nanogram per milliliter | Standard Deviation 0.64028 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 1.197 Nanogram per milliliter | Standard Deviation 0.85104 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0 | 0.7602 Nanogram per milliliter | Standard Deviation 0.6795 |
| Daprodustat | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0 | 1.690 Nanogram per milliliter | Standard Deviation 1.6309 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0 | 20.36 Nanogram per milliliter | Standard Deviation 22.21 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0 | 3.535 Nanogram per milliliter | Standard Deviation 2.7203 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0 | 2.734 Nanogram per milliliter | Standard Deviation 2.6846 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 3.508 Nanogram per milliliter | Standard Deviation 4.2066 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0 | 1.752 Nanogram per milliliter | Standard Deviation 1.8589 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0 | 4.145 Nanogram per milliliter | Standard Deviation 3.1757 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0 | 2.969 Nanogram per milliliter | Standard Deviation 2.4659 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 2.124 Nanogram per milliliter | Standard Deviation 2.8721 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0 | 2.338 Nanogram per milliliter | Standard Deviation 2.1467 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 0.5 hour, n=19,26,20,18,0,1,0,0,0 | 4.664 Nanogram per milliliter | Standard Deviation 8.7508 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0 | 15.58 Nanogram per milliliter | Standard Deviation 13.694 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0 | 1.979 Nanogram per milliliter | Standard Deviation 1.6316 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 2.788 Nanogram per milliliter | Standard Deviation 2.9893 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0 | 3.583 Nanogram per milliliter | Standard Deviation 2.8427 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0 | 21.45 Nanogram per milliliter | Standard Deviation 42.16 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 1.015 Nanogram per milliliter | Standard Deviation 3.1451 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 2.170 Nanogram per milliliter | Standard Deviation 1.6621 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0 | 1.807 Nanogram per milliliter | Standard Deviation 2.2007 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 2.729 Nanogram per milliliter | Standard Deviation 1.8934 |
| Darbepoetin Alfa | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0 | 2.610 Nanogram per milliliter | Standard Deviation 2.4761 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0 | 1.965 Nanogram per milliliter | Standard Deviation 2.283 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 0.5787 Nanogram per milliliter | Standard Deviation 1.5718 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 0.5 hour, n=19,26,20,18,0,1,0,0,0 | 10.27 Nanogram per milliliter | Standard Deviation 20.425 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0 | 36.78 Nanogram per milliliter | Standard Deviation 62.497 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0 | 54.68 Nanogram per milliliter | Standard Deviation 80.284 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0 | 43.34 Nanogram per milliliter | Standard Deviation 66.295 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 2.087 Nanogram per milliliter | Standard Deviation 2.1371 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0 | 1.822 Nanogram per milliliter | Standard Deviation 2.1355 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0 | 4.008 Nanogram per milliliter | Standard Deviation 4.4522 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0 | 5.553 Nanogram per milliliter | Standard Deviation 6.5157 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 3.879 Nanogram per milliliter | Standard Deviation 3.4207 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 3.315 Nanogram per milliliter | Standard Deviation 3.4249 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0 | 3.268 Nanogram per milliliter | Standard Deviation 3.4808 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0 | 4.989 Nanogram per milliliter | Standard Deviation 5.2109 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0 | 6.503 Nanogram per milliliter | Standard Deviation 7.513 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 3.750 Nanogram per milliliter | Standard Deviation 3.8006 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 3.263 Nanogram per milliliter | Standard Deviation 3.8737 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0 | 3.146 Nanogram per milliliter | Standard Deviation 4.0334 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0 | 3.711 Nanogram per milliliter | Standard Deviation 5.0223 |
| Daprodustat 4 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0 | 4.715 Nanogram per milliliter | Standard Deviation 7.2788 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0 | 3.776 Nanogram per milliliter | Standard Deviation 3.4411 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0 | 2.410 Nanogram per milliliter | Standard Deviation 2.8243 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 5.921 Nanogram per milliliter | Standard Deviation 5.8981 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 3.560 Nanogram per milliliter | Standard Deviation 4.2255 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0 | 4.892 Nanogram per milliliter | Standard Deviation 4.7877 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 4.015 Nanogram per milliliter | Standard Deviation 3.7385 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0 | 4.333 Nanogram per milliliter | Standard Deviation 3.0505 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0 | 56.49 Nanogram per milliliter | Standard Deviation 74.357 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0 | 7.130 Nanogram per milliliter | Standard Deviation 4.5105 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 2.867 Nanogram per milliliter | Standard Deviation 6.6142 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0 | 9.942 Nanogram per milliliter | Standard Deviation 7.0616 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0 | 55.62 Nanogram per milliliter | Standard Deviation 51.471 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 5.111 Nanogram per milliliter | Standard Deviation 4.0632 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0 | 45.48 Nanogram per milliliter | Standard Deviation 48.765 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 3.800 Nanogram per milliliter | Standard Deviation 2.8722 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 0.5 hour, n=19,26,20,18,0,1,0,0,0 | 12.58 Nanogram per milliliter | Standard Deviation 23.742 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0 | 6.631 Nanogram per milliliter | Standard Deviation 7.1049 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0 | 3.140 Nanogram per milliliter | Standard Deviation 2.4856 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0 | 6.336 Nanogram per milliliter | Standard Deviation 4.3723 |
| Daprodustat 6 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0 | 9.372 Nanogram per milliliter | Standard Deviation 6.6452 |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0 | 3.900 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 0.1030 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0 | 5.760 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0 | 6.090 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 8.710 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 5.660 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 4.450 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0 | 10.10 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0 | 3.950 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0 | 0.9120 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 7.740 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0 | 4.700 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0 | 8.930 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0 | 5.190 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0 | 4.810 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0 | 7.460 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0 | 25.30 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0 | 32.00 Nanogram per milliliter | — |
| Daprodustat 8 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 4.960 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0 | 10.00 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0 | 8.290 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0 | 19.60 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0 | 27.60 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0 | 22.00 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 0.1090 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0 | 79.60 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0 | 12.40 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 7.760 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0 | 10.20 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0 | 16.20 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 6.460 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 6.560 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 0.5 hour, n=19,26,20,18,0,1,0,0,0 | 145.0 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0 | 9.500 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0 | 6.740 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0 | 16.60 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0 | 8.110 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0 | 11.00 Nanogram per milliliter | — |
| Daprodustat 10 mg | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0 | 6.630 Nanogram per milliliter | — |