Anaemia
Conditions
Keywords
Daprodustat, ASCEND-P, Anemia, Chronic kidney disease, Erythropoiesis stimulating agent, Dialysis, Non-dialysis, 214066, 212914
Brief summary
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis \[ND\] and Dialysis \[D\]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis \[PD\] or hemodialysis \[HD\]). The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks). Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than \[\<\] 18 years, 6 to \<12 years, 2 to \<6 years, and 3 months to \<2 years). Except for PK and dose change, which is within each age group only.
Interventions
DRUGDaprodustat
Daprodustat will be administered up to Week 52.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label single arm trial, where all participants are on active treatment with daprodustat.
Eligibility
Sex/Gender
ALL
Age
3 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be 3 months to less than (\<)18 years of age. * Anemia associated with CKD stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent CKD, defined as Hgb 7.0 to 11.0 g/dL (if not using erythropoiesis stimulating agents \[ESAs\]) or Hgb 9.5 to 12.0 g/dL if using ESAs. * Written informed consent or assent as appropriate.
Exclusion criteria
* Kidney transplant recipient with a functioning allograft. * Scheduled for elective kidney transplantation within 3 months. * Transferrin saturation (TSAT) \< 20 percent (%), or Ferritin \<25 nanogram (ng)/milliliter (mL). * History of bone marrow aplasia or pure red cell aplasia. * Active hemolysis. * Other causes of anemia. * Active gastrointestinal bleeding within the last 4 weeks. * Active or previous malignancy within the last 2 years. * Acute or chronic infection requiring antimicrobial therapy. * History of significant thrombotic or thromboembolic events within the last 8 weeks. * Heart failure (HF) New York Heart Association (NYHA) Class IV * Uncontrolled hypertension. * Alanine aminotransferase (ALT) \>2× upper limit of normal (ULN), bilirubin \>1.5× ULN (unless bilirubin is fractionated and direct bilirubin \<35%), and cirrhosis or current unstable liver or biliary disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 56 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator. |
| Number of Participants With Adverse Event of Special Interests (AESIs) | Up to 56 weeks | AESIs are AEs of scientific interest specific to the drug class as per investigator assessment. AESI included: Death, Myocardial Infarction (MI), stroke, Heart Failure (HF), thromboembolic events, thrombosis of vascular access, Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis, New diagnosis of hypertension or worsening of existing hypertension, Cancer related mortality and tumor progression and recurrence, Esophageal and gastric erosions. Number of participants with any AESIs have been presented. |
| Number of Participants With AEs Leading to Study Intervention Discontinuation | Up to 52 weeks | All AEs leading to study intervention discontinuation were collected. Number of participants with any AEs leading to study intervention discontinuation have been presented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameters: Calcium, Potassium, Sodium and BUN. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Creatinine | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameter: Creatinine. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameters: Bilirubin and Direct Bilirubin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Protein | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameter: Protein. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Ferritin | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameter: Ferritin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameter: Transferrin saturation. Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameter: Estimated Glomerular Filtration Rate. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Prothrombin International Normalized Ratio. It is used to assess the clotting ability of blood. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Heart Rate (HR) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Heart rate (HR) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Weight | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Weight readings in kilogram (kg) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Height | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Height readings in centimeters (cm) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Absolute Values of Hemoglobin (Hgb) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected from all participants for measurement of Hgb values in grams per deciliter (g/dL). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Hgb results of participants with intercurrent events were excluded from the summary. |
| Change From Baseline in Hemoglobin (Hgb) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected from all participants for measurement of Hgb values in g/dL. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Hgb results of participants with intercurrent events were excluded from the summary. |
| Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Number of participants with Hgb values above, below, and within the target range (10 to 12 g/dL) were assessed. Baseline assessment was defined as the last non-missing value prior to the start date and time of the study drug (Day 1). Hgb results of participants with intercurrent events were excluded from the summary. |
| Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Day 1 (Baseline), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Daprodustat dose was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for Hgb between 10 to 12 g/dL. Dose change values of daprodustat from starting dose at each study time point were calculated as dose level at indicated time point minus starting dose at Day 1 (Baseline). |
| Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | Up to Week 52 | Number of participants who required daprodustat dose adjustments form the starting dose were assessed. Data were categorized for number of participants who required no dose change (0 times) to 10 times and \>10 times dose adjustments during the study. |
| Daprodustat Dose at Each Study Time Point | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Mean and standard deviation of daprodustat dose received by participants at each study time point has been presented. |
| Maximum Plasma Concentration (Cmax) of Daprodustat | Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose | Blood samples were collected for the plasma concentrations of daprodustat from which pharmacokinetic (PK) parameters were determined. Mean and standard deviation of daprodustat Cmax at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). |
| Area Under the Curve (AUC) at Steady State of Daprodustat | Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose | Blood samples were collected for the plasma concentrations of daprodustat from which PK parameters were determined. Mean and standard deviation of daprodustat AUC at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). |
| Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | Pre-dose on Week 2 | Blood samples were collected for the plasma concentrations of daprodustat and metabolites from which PK parameters were determined. Mean and standard deviation of raw daprodustat and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401) at steady state at pre-dose obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Systolic and diastolic blood pressure (BP) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Reticulocytes/Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
Countries
Japan, South Korea
Participant flow
Recruitment details
Participants were enrolled into two sub-trials based on dialysis status under a master protocol. The non-dialysis (ND) sub-trial enrolled pediatric participants with anemia associated with chronic kidney disease (CKD) not yet requiring dialysis in non-US countries. The dialysis (D) sub-trial enrolled pediatric participants with anemia associated with CKD requiring dialysis in non-US countries. Recruitment was conducted separately for each sub-trial.
Pre-assignment details
A total of 4 participants were enrolled. As pre-specified in protocol design, data for the 2 sub-trials (ND and D) have been presented in two arms for this study.
Participants by arm
| Arm | Count |
|---|---|
| Participants Requiring Dialysis (D) Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). | 2 |
| Participants Not Yet Requiring Dialysis (ND) Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Participants Requiring Dialysis (D) | Participants Not Yet Requiring Dialysis (ND) | Total |
|---|---|---|---|
| Age, Customized 12 to <18 years | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized All Other Races | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 2 / 2 | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 | 0 / 2 |
Outcome results
Primary
Number of Participants With Adverse Event of Special Interests (AESIs)
AESIs are AEs of scientific interest specific to the drug class as per investigator assessment. AESI included: Death, Myocardial Infarction (MI), stroke, Heart Failure (HF), thromboembolic events, thrombosis of vascular access, Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis, New diagnosis of hypertension or worsening of existing hypertension, Cancer related mortality and tumor progression and recurrence, Esophageal and gastric erosions. Number of participants with any AESIs have been presented.
Time frame: Up to 56 weeks
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Requiring Dialysis (D) | Number of Participants With Adverse Event of Special Interests (AESIs) | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Adverse Event of Special Interests (AESIs) | 0 Participants |
Primary
Number of Participants With AEs Leading to Study Intervention Discontinuation
All AEs leading to study intervention discontinuation were collected. Number of participants with any AEs leading to study intervention discontinuation have been presented
Time frame: Up to 52 weeks
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Requiring Dialysis (D) | Number of Participants With AEs Leading to Study Intervention Discontinuation | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With AEs Leading to Study Intervention Discontinuation | 0 Participants |
Primary
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator.
Time frame: Up to 56 weeks
Population: The analysis was performed on the Safety Set that included all participants who were enrolled and took at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Requiring Dialysis (D) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 2 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
Secondary
Absolute Values of Hemoglobin (Hgb)
Blood samples were collected from all participants for measurement of Hgb values in grams per deciliter (g/dL). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Hgb results of participants with intercurrent events were excluded from the summary.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Absolute Values of Hemoglobin (Hgb) | Baseline (Day 1) | 11.00 grams per deciliter | Standard Deviation 0.424 |
| Participants Requiring Dialysis (D) | Absolute Values of Hemoglobin (Hgb) | Week 4 | 11.80 grams per deciliter | — |
| Participants Requiring Dialysis (D) | Absolute Values of Hemoglobin (Hgb) | Week 2 | 10.85 grams per deciliter | Standard Deviation 1.061 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 32 | 11.80 grams per deciliter | — |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 36 | 11.95 grams per deciliter | Standard Deviation 0.354 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 40 | 12.10 grams per deciliter | — |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Baseline (Day 1) | 11.35 grams per deciliter | Standard Deviation 0.919 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 2 | 11.90 grams per deciliter | Standard Deviation 0.99 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 4 | 11.50 grams per deciliter | Standard Deviation 0.566 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 16 | 10.95 grams per deciliter | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 20 | 11.55 grams per deciliter | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 24 | 11.70 grams per deciliter | Standard Deviation 0.141 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 44 | 11.20 grams per deciliter | — |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 48 | 11.90 grams per deciliter | — |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 8 | 11.65 grams per deciliter | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 52 | 12.60 grams per deciliter | — |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 12 | 11.80 grams per deciliter | Standard Deviation 0.283 |
| Participants Not Yet Requiring Dialysis (ND) | Absolute Values of Hemoglobin (Hgb) | Week 28 | 11.65 grams per deciliter | Standard Deviation 0.354 |
Secondary
Area Under the Curve (AUC) at Steady State of Daprodustat
Blood samples were collected for the plasma concentrations of daprodustat from which PK parameters were determined. Mean and standard deviation of daprodustat AUC at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis).
Time frame: Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose
Population: All Pharmacokinetic Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Requiring Dialysis (D) | Area Under the Curve (AUC) at Steady State of Daprodustat | 185.379 Hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 8.661 |
| Participants Not Yet Requiring Dialysis (ND) | Area Under the Curve (AUC) at Steady State of Daprodustat | 56.634 Hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 6.009 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Blood samples were collected to analyze the clinical chemistry parameter: Creatinine. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 4 | 21.2160 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 12 | -1.7680 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 20 | -22.1000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 28 | 78.6760 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 36 | 95.4720 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 40 | 100.7760 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 52 | 151.1640 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 8 | 139.6720 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 16 | 4.4200 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 24 | -5.3040 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 32 | 83.9800 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 44 | 115.8040 micromoles per Liter (µmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 36 | 32.2660 micromoles per Liter (µmol/L) | Standard Deviation 45.63101 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 4 | -3.0940 micromoles per Liter (µmol/L) | Standard Deviation 5.62574 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 24 | 24.3100 micromoles per Liter (µmol/L) | Standard Deviation 26.87854 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 12 | 3.9780 micromoles per Liter (µmol/L) | Standard Deviation 10.6264 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 8 | -0.4420 micromoles per Liter (µmol/L) | Standard Deviation 9.37624 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 52 | 73.8140 micromoles per Liter (µmol/L) | Standard Deviation 94.38744 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 28 | 13.7020 micromoles per Liter (µmol/L) | Standard Deviation 13.12673 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 32 | 48.6200 micromoles per Liter (µmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 16 | 14.5860 micromoles per Liter (µmol/L) | Standard Deviation 19.37755 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 20 | 12.3760 micromoles per Liter (µmol/L) | Standard Deviation 6.25082 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 40 | 65.4160 micromoles per Liter (µmol/L) | Standard Deviation 75.00989 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 44 | 49.5040 micromoles per Liter (µmol/L) | Standard Deviation 57.50758 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Week 48 | 56.1340 micromoles per Liter (µmol/L) | Standard Deviation 65.63365 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Blood samples were collected to analyze the clinical chemistry parameter: Estimated Glomerular Filtration Rate. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 20 | 0.440 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 28 | -0.930 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 32 | -1.320 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 36 | -1.460 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 8 | -2.020 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 40 | -1.580 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 12 | 0.040 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 44 | -1.770 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 24 | 0.130 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 16 | -0.060 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 52 | -2.260 mL per minute per 1.73 square meter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 4 | -0.380 mL per minute per 1.73 square meter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 8 | -0.310 mL per minute per 1.73 square meter | Standard Deviation 2.4042 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 52 | -5.935 mL per minute per 1.73 square meter | Standard Deviation 6.6539 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 20 | -1.740 mL per minute per 1.73 square meter | Standard Deviation 0.3253 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 24 | -2.655 mL per minute per 1.73 square meter | Standard Deviation 2.3405 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 32 | -4.650 mL per minute per 1.73 square meter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 4 | 0.615 mL per minute per 1.73 square meter | Standard Deviation 0.799 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 12 | -1.095 mL per minute per 1.73 square meter | Standard Deviation 3.0335 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 16 | -1.530 mL per minute per 1.73 square meter | Standard Deviation 2.0365 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 28 | -1.200 mL per minute per 1.73 square meter | Standard Deviation 1.2445 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 36 | -2.370 mL per minute per 1.73 square meter | Standard Deviation 5.1053 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 40 | -6.565 mL per minute per 1.73 square meter | Standard Deviation 4.3346 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 44 | -4.855 mL per minute per 1.73 square meter | Standard Deviation 4.08 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Week 48 | -5.410 mL per minute per 1.73 square meter | Standard Deviation 4.4548 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Blood samples were collected to analyze the clinical chemistry parameter: Ferritin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 12 | 28.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 16 | -29.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 32 | -14.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 36 | 42.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 40 | 42.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 4 | -32.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 8 | 167.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 20 | -35.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 24 | -33.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 28 | -36.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 44 | 75.00 micrograms per liter (µg/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 52 | 39.00 micrograms per liter (µg/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 28 | -27.65 micrograms per liter (µg/L) | Standard Deviation 25.951 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 8 | -17.30 micrograms per liter (µg/L) | Standard Deviation 12.304 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 12 | -23.30 micrograms per liter (µg/L) | Standard Deviation 19.375 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 52 | -5.05 micrograms per liter (µg/L) | Standard Deviation 56.498 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 16 | -24.95 micrograms per liter (µg/L) | Standard Deviation 9.97 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 20 | -28.50 micrograms per liter (µg/L) | Standard Deviation 13.435 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 32 | -22.00 micrograms per liter (µg/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 44 | -3.00 micrograms per liter (µg/L) | Standard Deviation 59.397 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 36 | -31.00 micrograms per liter (µg/L) | Standard Deviation 12.728 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 24 | -26.95 micrograms per liter (µg/L) | Standard Deviation 22.698 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 40 | -9.60 micrograms per liter (µg/L) | Standard Deviation 37.335 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 48 | -16.30 micrograms per liter (µg/L) | Standard Deviation 50.487 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Week 4 | -12.60 micrograms per liter (µg/L) | Standard Deviation 20.365 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Protein
Blood samples were collected to analyze the clinical chemistry parameter: Protein. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 4 | 6.00 Grams per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 8 | 5.00 Grams per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 12 | -1.00 Grams per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 24 | 2.00 Grams per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 32 | 4.00 Grams per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 36 | 6.00 Grams per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 40 | 3.00 Grams per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 52 | 3.00 Grams per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 40 | 2.25 Grams per liter | Standard Deviation 5.303 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 32 | 2.00 Grams per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 4 | -2.30 Grams per liter | Standard Deviation 1.838 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 48 | 0.10 Grams per liter | Standard Deviation 2.687 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 8 | -1.85 Grams per liter | Standard Deviation 1.202 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 36 | -1.65 Grams per liter | Standard Deviation 3.748 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 12 | -2.65 Grams per liter | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 52 | -0.65 Grams per liter | Standard Deviation 2.333 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Protein | Week 24 | -1.45 Grams per liter | Standard Deviation 2.051 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 12 | 31.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 12 | 2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 24 | 0.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 36 | -1.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 40 | -2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 52 | 0.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 4 | 34.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 24 | 36.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 40 | -3.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 32 | 29.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 36 | 14.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 40 | 2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 52 | 2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 4 | 3.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 8 | 5.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 12 | 0.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 24 | -1.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 32 | 1.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 36 | -2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 52 | -2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 4 | 2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 8 | 2.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 32 | 1.0 International units per liter | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 8 | 13.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 24 | -5.5 International units per liter | Standard Deviation 3.54 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 36 | 113.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 8 | -2.5 International units per liter | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 40 | 100.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 48 | 35.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 24 | -3.5 International units per liter | Standard Deviation 2.12 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 12 | -3.5 International units per liter | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 32 | -4.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 32 | -5.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 52 | 46.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 36 | -1.0 International units per liter | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 4 | -2.0 International units per liter | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 40 | -3.5 International units per liter | Standard Deviation 2.12 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 48 | -0.5 International units per liter | Standard Deviation 4.95 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 4 | -1.0 International units per liter | Standard Deviation 1.41 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT: Week 52 | -4.5 International units per liter | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 48 | -4.5 International units per liter | Standard Deviation 4.95 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 8 | 77.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 12 | 123.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 4 | -29.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 8 | -1.0 International units per liter | Standard Deviation 1.41 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 36 | -2.5 International units per liter | Standard Deviation 3.54 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 12 | -4.0 International units per liter | Standard Deviation 2.83 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 40 | -4.0 International units per liter | Standard Deviation 4.24 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 24 | 23.0 International units per liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST: Week 52 | -6.0 International units per liter | Standard Deviation 4.24 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP: Week 32 | 141.0 International units per liter | — |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Blood samples were collected to analyze the clinical chemistry parameters: Bilirubin and Direct Bilirubin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 40 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 4 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 24 | -1.7100 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 52 | -1.7100 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 4 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 8 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 32 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 12 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 24 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 52 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 32 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 36 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 36 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 12 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 40 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 8 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 32 | 0.0000 micromoles per Liter (µmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 36 | 0.0855 micromoles per Liter (µmol/L) | Standard Deviation 0.12092 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 40 | 0.0000 micromoles per Liter (µmol/L) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 8 | 1.5390 micromoles per Liter (µmol/L) | Standard Deviation 2.17647 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 52 | 1.6245 micromoles per Liter (µmol/L) | Standard Deviation 2.29739 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 12 | 0.4275 micromoles per Liter (µmol/L) | Standard Deviation 0.60458 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 48 | 0.0855 micromoles per Liter (µmol/L) | Standard Deviation 0.12092 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 52 | 0.0855 micromoles per Liter (µmol/L) | Standard Deviation 0.12092 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 4 | 1.1115 micromoles per Liter (µmol/L) | Standard Deviation 1.5719 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 12 | 3.4200 micromoles per Liter (µmol/L) | Standard Deviation 4.83661 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 24 | 4.9590 micromoles per Liter (µmol/L) | Standard Deviation 2.17647 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 32 | 3.4200 micromoles per Liter (µmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 36 | 1.9665 micromoles per Liter (µmol/L) | Standard Deviation 0.36275 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 40 | 3.5910 micromoles per Liter (µmol/L) | Standard Deviation 0.24183 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Bilirubin: Week 48 | -0.3420 micromoles per Liter (µmol/L) | Standard Deviation 0.48366 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 4 | 0.0000 micromoles per Liter (µmol/L) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 8 | 0.1710 micromoles per Liter (µmol/L) | Standard Deviation 0.24183 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Direct Bilirubin: Week 24 | 0.4275 micromoles per Liter (µmol/L) | Standard Deviation 0.60458 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Blood samples were collected to analyze the clinical chemistry parameters: Calcium, Potassium, Sodium and BUN. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 8 | -0.1248 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 12 | 1.7136 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 4 | 0.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 16 | 1.3923 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 24 | 0.6069 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 44 | 0.1248 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 40 | -0.6426 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 8 | 0.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 44 | 2.2848 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 24 | 0.0250 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 52 | 1.9278 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 28 | -0.0499 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 12 | -1.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 32 | 0.0250 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 52 | 0.0998 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 16 | 0.0000 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 12 | 0.40 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 16 | 0.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 16 | 0.10 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 12 | -0.0499 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 28 | 0.30 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 20 | 1.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 32 | 0.30 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 4 | 0.40 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 36 | 0.20 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 24 | 0.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 40 | 0.40 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 36 | 0.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 44 | 0.20 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 36 | 0.1248 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 32 | 0.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 8 | 0.30 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 28 | -2.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 40 | 0.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 20 | 0.0250 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 44 | 1.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 8 | -0.2142 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 20 | 0.30 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 20 | 0.7854 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 40 | 0.0000 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 28 | 3.6057 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 52 | -1.0 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 32 | 2.2134 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 24 | 0.20 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 36 | 4.1055 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 4 | 0.9996 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 52 | 0.50 millimoles per liter (mmol/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 4 | 0.0749 millimoles per liter (mmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 28 | 0.0893 millimoles per liter (mmol/L) | Standard Deviation 2.90303 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 32 | 1.4280 millimoles per liter (mmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 36 | 0.4820 millimoles per liter (mmol/L) | Standard Deviation 1.33792 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 48 | 0.4463 millimoles per liter (mmol/L) | Standard Deviation 2.90303 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 52 | 1.1424 millimoles per liter (mmol/L) | Standard Deviation 4.94777 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 4 | -0.1123 millimoles per liter (mmol/L) | Standard Deviation 0.05293 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 8 | -0.1248 millimoles per liter (mmol/L) | Standard Deviation 0.10585 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 12 | -0.1372 millimoles per liter (mmol/L) | Standard Deviation 0.1235 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 16 | -0.1372 millimoles per liter (mmol/L) | Standard Deviation 0.1235 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 20 | -0.0873 millimoles per liter (mmol/L) | Standard Deviation 0.08821 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 24 | -0.0873 millimoles per liter (mmol/L) | Standard Deviation 0.15878 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 32 | 0.0000 millimoles per liter (mmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 36 | -0.1372 millimoles per liter (mmol/L) | Standard Deviation 0.1235 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 40 | -0.0624 millimoles per liter (mmol/L) | Standard Deviation 0.05293 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 44 | -0.1248 millimoles per liter (mmol/L) | Standard Deviation 0.07057 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 48 | -0.1123 millimoles per liter (mmol/L) | Standard Deviation 0.08821 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 52 | -0.1747 millimoles per liter (mmol/L) | Standard Deviation 0.14114 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 4 | -0.35 millimoles per liter (mmol/L) | Standard Deviation 0.354 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 16 | -0.45 millimoles per liter (mmol/L) | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 20 | -0.10 millimoles per liter (mmol/L) | Standard Deviation 0.424 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 52 | -0.20 millimoles per liter (mmol/L) | Standard Deviation 0.283 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 4 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 3.54 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 8 | -0.5 millimoles per liter (mmol/L) | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 12 | 0.0 millimoles per liter (mmol/L) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 16 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 3.54 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 20 | -2.0 millimoles per liter (mmol/L) | Standard Deviation 2.83 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 28 | -0.5 millimoles per liter (mmol/L) | Standard Deviation 3.54 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 32 | -3.0 millimoles per liter (mmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 36 | -0.5 millimoles per liter (mmol/L) | Standard Deviation 2.12 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 44 | -0.5 millimoles per liter (mmol/L) | Standard Deviation 4.95 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 48 | -1.0 millimoles per liter (mmol/L) | Standard Deviation 2.83 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 52 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.12 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 4 | 0.0893 millimoles per liter (mmol/L) | Standard Deviation 3.4079 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 8 | 2.1242 millimoles per liter (mmol/L) | Standard Deviation 4.06424 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 12 | 0.6962 millimoles per liter (mmol/L) | Standard Deviation 2.54961 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 24 | 0.0000 millimoles per liter (mmol/L) | Standard Deviation 3.02925 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 40 | 4.1948 millimoles per liter (mmol/L) | Standard Deviation 7.19446 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 44 | 1.1603 millimoles per liter (mmol/L) | Standard Deviation 2.90303 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium: Week 28 | -0.1871 millimoles per liter (mmol/L) | Standard Deviation 0.08821 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 8 | -0.40 millimoles per liter (mmol/L) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 12 | -0.30 millimoles per liter (mmol/L) | Standard Deviation 0.283 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 24 | -0.05 millimoles per liter (mmol/L) | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 28 | -0.55 millimoles per liter (mmol/L) | Standard Deviation 0.354 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 32 | -0.30 millimoles per liter (mmol/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 36 | -0.35 millimoles per liter (mmol/L) | Standard Deviation 0.071 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 40 | -0.55 millimoles per liter (mmol/L) | Standard Deviation 0.354 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 44 | -0.40 millimoles per liter (mmol/L) | Standard Deviation 0.424 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium: Week 48 | -0.25 millimoles per liter (mmol/L) | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 24 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.12 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium: Week 40 | -2.5 millimoles per liter (mmol/L) | Standard Deviation 3.54 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 16 | 0.1964 millimoles per liter (mmol/L) | Standard Deviation 4.77106 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN: Week 20 | 0.8390 millimoles per liter (mmol/L) | Standard Deviation 0.83304 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Blood samples were collected to analyze the clinical chemistry parameter: Transferrin saturation. Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 4 | -6.900 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 12 | 6.500 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 8 | -2.300 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 16 | -0.900 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 32 | -8.100 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 36 | 3.100 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 24 | -7.770 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 40 | 3.100 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 20 | -3.600 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 44 | -7.600 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 52 | -1.500 Percentage (%) of transferrin saturation | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 28 | -6.900 Percentage (%) of transferrin saturation | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 4 | -14.990 Percentage (%) of transferrin saturation | Standard Deviation 43.8548 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 52 | -7.520 Percentage (%) of transferrin saturation | Standard Deviation 51.5905 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 8 | 6.385 Percentage (%) of transferrin saturation | Standard Deviation 7.6155 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 20 | -18.500 Percentage (%) of transferrin saturation | Standard Deviation 55.8614 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 24 | -12.995 Percentage (%) of transferrin saturation | Standard Deviation 55.1614 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 28 | -29.050 Percentage (%) of transferrin saturation | Standard Deviation 56.4978 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 32 | -69.000 Percentage (%) of transferrin saturation | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 44 | -27.305 Percentage (%) of transferrin saturation | Standard Deviation 27.8529 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 48 | -25.715 Percentage (%) of transferrin saturation | Standard Deviation 28.6873 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 12 | -18.245 Percentage (%) of transferrin saturation | Standard Deviation 68.95 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 16 | -2.775 Percentage (%) of transferrin saturation | Standard Deviation 4.5608 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 36 | -31.620 Percentage (%) of transferrin saturation | Standard Deviation 62.7628 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Week 40 | -32.230 Percentage (%) of transferrin saturation | Standard Deviation 52.0006 |
Secondary
Change From Baseline in Heart Rate (HR)
Heart rate (HR) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 52 | -3.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 4 | 2.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 12 | 5.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 16 | -10.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 40 | -1.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 44 | 12.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 8 | 15.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 20 | 0.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 24 | 8.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 28 | 14.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 32 | 11.0 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 36 | 1.00 beats per minute (bpm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Heart Rate (HR) | Week 2 | -12.5 beats per minute (bpm) | Standard Deviation 9.19 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 44 | -3.5 beats per minute (bpm) | Standard Deviation 12.02 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 8 | -8.0 beats per minute (bpm) | Standard Deviation 28.28 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 2 | -9.0 beats per minute (bpm) | Standard Deviation 4.24 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 12 | -11.0 beats per minute (bpm) | Standard Deviation 43.84 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 4 | -2.0 beats per minute (bpm) | Standard Deviation 18.38 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 16 | -12.0 beats per minute (bpm) | Standard Deviation 14.14 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 40 | 30.0 beats per minute (bpm) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 20 | 4.0 beats per minute (bpm) | Standard Deviation 14.14 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 28 | 3.0 beats per minute (bpm) | Standard Deviation 5.66 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 36 | 3.5 beats per minute (bpm) | Standard Deviation 7.78 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 32 | -12.0 beats per minute (bpm) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 24 | 5.5 beats per minute (bpm) | Standard Deviation 6.36 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 48 | -17.5 beats per minute (bpm) | Standard Deviation 14.85 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Heart Rate (HR) | Week 52 | 3.0 beats per minute (bpm) | Standard Deviation 1.41 |
Secondary
Change From Baseline in Height
Height readings in centimeters (cm) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 20 | 0.30 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 24 | 0.30 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 28 | 1.00 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 32 | 0.80 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 2 | -1.50 centimeters (cm) | Standard Deviation 2.121 |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 4 | 0.00 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 8 | 0.00 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 12 | 0.00 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 16 | 0.10 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 36 | 0.50 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 40 | 0.20 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 44 | 0.20 centimeters (cm) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Height | Week 52 | -0.70 centimeters (cm) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 32 | 5.30 centimeters (cm) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 8 | 1.20 centimeters (cm) | Standard Deviation 0.707 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 20 | 3.35 centimeters (cm) | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 40 | 4.50 centimeters (cm) | Standard Deviation 2.546 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 24 | 3.70 centimeters (cm) | Standard Deviation 0.707 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 12 | 2.65 centimeters (cm) | Standard Deviation 0.071 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 52 | 6.25 centimeters (cm) | Standard Deviation 2.333 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 36 | 5.00 centimeters (cm) | Standard Deviation 1.131 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 44 | 5.65 centimeters (cm) | Standard Deviation 2.192 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 48 | 5.65 centimeters (cm) | Standard Deviation 2.192 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 16 | 1.85 centimeters (cm) | Standard Deviation 1.485 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 2 | 0.85 centimeters (cm) | Standard Deviation 1.202 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 28 | 4.60 centimeters (cm) | Standard Deviation 0.141 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Height | Week 4 | 0.95 centimeters (cm) | Standard Deviation 0.495 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 28 | 0.250 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 8 | 0.480 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 32 | 0.350 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 16 | -0.350 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 36 | 0.030 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 4 | 0.130 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 40 | -0.330 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 44 | -0.260 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 20 | 0.010 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 12 | -0.350 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 52 | -0.490 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 24 | 0.030 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 24 | 0.025 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.3889 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 52 | -0.050 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.2687 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 40 | 0.310 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.4808 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 4 | 0.060 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.4243 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 8 | 0.045 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.4313 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 12 | 0.060 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.2546 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 16 | -0.280 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.5374 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 20 | -0.050 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.297 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 28 | -0.095 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.4879 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 32 | 0.350 Trillion cells per Liter (10^12 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 36 | 0.050 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.3111 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 44 | -0.080 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.5515 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes | Week 48 | -0.025 Trillion cells per Liter (10^12 cells/L) | Standard Deviation 0.2758 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 4 | 0.30 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 8 | 0.20 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 12 | 0.70 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 16 | 1.30 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 20 | 0.90 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | 1.30 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 28 | 1.20 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 32 | 1.00 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 36 | 0.50 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 40 | 1.60 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 44 | 2.10 Picogram (pg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 52 | 1.80 Picogram (pg) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 40 | 0.55 Picogram (pg) | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 28 | 1.45 Picogram (pg) | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 4 | 0.00 Picogram (pg) | Standard Deviation 0.849 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 52 | 1.95 Picogram (pg) | Standard Deviation 1.626 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 8 | 0.45 Picogram (pg) | Standard Deviation 0.071 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 32 | 0.40 Picogram (pg) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 12 | 0.70 Picogram (pg) | Standard Deviation 0.141 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 44 | 0.55 Picogram (pg) | Standard Deviation 1.061 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 16 | 0.95 Picogram (pg) | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 36 | 1.15 Picogram (pg) | Standard Deviation 0.636 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 20 | 0.85 Picogram (pg) | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 48 | 0.80 Picogram (pg) | Standard Deviation 0.566 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | 0.70 Picogram (pg) | Standard Deviation 0 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 36 | 1.00 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 24 | 0.60 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 12 | 1.00 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 52 | 3.40 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 28 | 2.60 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 4 | 1.00 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 20 | -0.20 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 8 | 2.10 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 40 | 2.10 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 32 | 0.80 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 44 | 5.60 Femtoliter (fL) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 16 | 3.10 Femtoliter (fL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 8 | -0.35 Femtoliter (fL) | Standard Deviation 0.919 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 44 | 0.20 Femtoliter (fL) | Standard Deviation 1.98 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 12 | 2.00 Femtoliter (fL) | Standard Deviation 1.414 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 16 | 1.15 Femtoliter (fL) | Standard Deviation 1.344 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 20 | 0.85 Femtoliter (fL) | Standard Deviation 1.202 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 24 | 0.95 Femtoliter (fL) | Standard Deviation 1.202 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 28 | 0.70 Femtoliter (fL) | Standard Deviation 1.131 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 32 | 1.90 Femtoliter (fL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 36 | 1.25 Femtoliter (fL) | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 48 | 1.35 Femtoliter (fL) | Standard Deviation 0.778 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 52 | 1.45 Femtoliter (fL) | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 4 | -0.45 Femtoliter (fL) | Standard Deviation 0.919 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Week 40 | 0.35 Femtoliter (fL) | Standard Deviation 1.626 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 28 | 0.0340 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 12 | -0.0280 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 32 | 0.0350 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 20 | 0.0000 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 36 | 0.0070 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 8 | 0.0530 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 40 | -0.0220 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 44 | -0.0020 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 24 | 0.0050 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 4 | 0.0160 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 52 | -0.0320 Percentage of red blood cells in blood | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Hematocrit | Week 16 | -0.0200 Percentage of red blood cells in blood | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 48 | 0.0035 Percentage of red blood cells in blood | Standard Deviation 0.01909 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 52 | 0.0020 Percentage of red blood cells in blood | Standard Deviation 0.0198 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 16 | -0.0185 Percentage of red blood cells in blood | Standard Deviation 0.03889 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 40 | 0.0270 Percentage of red blood cells in blood | Standard Deviation 0.04667 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 4 | 0.0030 Percentage of red blood cells in blood | Standard Deviation 0.03818 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 8 | 0.0025 Percentage of red blood cells in blood | Standard Deviation 0.03889 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 12 | 0.0135 Percentage of red blood cells in blood | Standard Deviation 0.01485 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 20 | -0.0005 Percentage of red blood cells in blood | Standard Deviation 0.01909 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 24 | 0.0060 Percentage of red blood cells in blood | Standard Deviation 0.02687 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 28 | -0.0050 Percentage of red blood cells in blood | Standard Deviation 0.03536 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 32 | 0.0370 Percentage of red blood cells in blood | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 36 | 0.0095 Percentage of red blood cells in blood | Standard Deviation 0.02333 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Hematocrit | Week 44 | -0.0060 Percentage of red blood cells in blood | Standard Deviation 0.03677 |
Secondary
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Blood samples were collected to analyze the hematology parameter: Prothrombin International Normalized Ratio. It is used to assess the clotting ability of blood. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 12 | 0.010 Ratio |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 52 | 0.030 Ratio |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 24 | -0.040 Ratio |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 40 | 0.030 Ratio |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 32 | -0.010 Ratio |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 36 | 0.010 Ratio |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 4 | -0.010 Ratio |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 8 | -0.040 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 48 | -0.010 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 8 | 0.050 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 40 | 0.010 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 52 | 0.040 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 4 | -0.010 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 12 | 0.030 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 24 | 0.010 Ratio |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Week 36 | -0.020 Ratio |
Secondary
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Blood samples were collected to analyze the hematology parameter: Reticulocytes/Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 16 | 0.0100 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 32 | 0.0030 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 8 | -0.0020 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 36 | 0.0020 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 20 | 0.0110 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 40 | 0.0070 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 12 | 0.0060 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 44 | 0.0100 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 24 | 0.0060 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 4 | 0.0080 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 52 | 0.0040 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 28 | 0.0040 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 4 | -0.0039 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00686 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 52 | 0.0018 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00453 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 8 | 0.0031 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00134 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 12 | -0.0012 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00594 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 16 | -0.0024 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00481 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 20 | 0.0001 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00693 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 24 | -0.0020 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.007 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 28 | 0.0007 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00467 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 32 | -0.0037 Ratio of Reticulocytes to Erythrocytes | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 36 | 0.0010 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00573 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 40 | -0.0020 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00849 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 44 | 0.0010 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00714 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Week 48 | 0.0026 Ratio of Reticulocytes to Erythrocytes | Standard Deviation 0.00771 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 32 | -6.970 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 36 | -0.0091 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 4 | 0.0408 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 40 | -0.0020 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 36 | 1.140 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 44 | -0.0091 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 36 | 1.2095 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 40 | -0.680 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 52 | 0.0012 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 36 | -0.0410 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 4 | 0.0146 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 44 | 1.160 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 8 | -0.0962 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 40 | -0.2730 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 12 | -0.0072 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 16 | 0.0239 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 52 | 0.4700 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 20 | -0.0037 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 52 | 0.400 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 24 | 0.0203 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 44 | 0.5974 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 28 | -0.0578 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 8 | 0.1094 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 32 | -0.1571 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 44 | 0.0601 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 36 | -0.0775 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 52 | -0.0248 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 40 | -0.1208 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 44 | -0.0522 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 20 | 5.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 52 | 0.0164 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 52 | -0.0628 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 24 | -11.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 4 | 0.2799 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 4 | 0.150 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 8 | 0.4370 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 28 | 10.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 12 | -0.2165 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 36 | 0.0581 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 16 | -0.2907 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 32 | 6.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 20 | 0.1325 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 8 | -3.160 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 24 | -0.1535 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 36 | -4.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 28 | 0.0289 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 12 | -0.0258 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 32 | -1.1501 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 40 | -0.2134 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 40 | 23.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 44 | 0.5638 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 44 | 28.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 16 | -0.0289 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 12 | -0.360 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 20 | 0.0132 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 4 | 0.0120 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 24 | -0.0404 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 24 | -1.2919 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 32 | -0.2902 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 8 | -0.0177 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 40 | -0.0708 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 16 | -2.070 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 12 | -0.0011 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 4 | -0.1973 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 28 | 1.6839 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 8 | -3.5926 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 16 | -0.0062 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 12 | -0.1094 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 24 | -1.470 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 16 | -1.7681 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 20 | 0.0085 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 20 | -0.8705 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 28 | 0.0169 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 24 | -0.0044 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 20 | -0.720 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 28 | 1.690 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 4 | 16.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 8 | -31.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 12 | -11.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 16 | -5.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 28 | 0.0182 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 32 | -5.3517 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 52 | 30.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 32 | -0.0209 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 16 | 1.3315 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.2707 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 24 | 0.2346 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.30353 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 16 | 1.240 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.6505 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 52 | 0.170 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.3253 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 40 | -18.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 27.58 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 48 | -36.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 35.36 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 12 | 0.2547 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.11973 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 52 | 11.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 65.05 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 40 | 0.0357 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.07683 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 32 | 0.6357 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 36 | -0.4619 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.00143 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 44 | -0.4021 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5062 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 48 | -0.1701 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.33923 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 52 | -0.5256 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.60026 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 4 | -0.0318 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.03079 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 8 | 0.0230 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.15981 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 28 | -0.0314 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.06868 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 36 | -0.0596 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0136 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 40 | 0.0884 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.20985 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 52 | -0.0112 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.01583 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 20 | -0.0296 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.38241 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 28 | -0.1160 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.33096 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 32 | 1.1306 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 36 | 0.4269 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.70272 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 40 | 1.0158 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.85667 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 44 | 0.0185 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.11095 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 48 | 0.3055 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.11948 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 52 | 0.6728 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.91533 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 4 | -0.045 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.7849 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 8 | 0.315 Giga cells per Liter (10^9 cells/L) | Standard Deviation 2.4254 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 12 | 0.510 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5798 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 20 | -0.315 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.2516 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 24 | -0.060 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.1879 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 28 | -0.385 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.0112 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 32 | 2.130 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 36 | -0.070 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.8809 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 40 | 0.605 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.997 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 44 | -0.390 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.7212 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Leukocytes: Week 48 | 0.310 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4384 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 4 | -30.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 26.87 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 8 | -41.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 34.65 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 12 | -32.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 39.6 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 16 | -47.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 14.14 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 20 | -39.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 27.58 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 24 | -10.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 7.07 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 28 | -14.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 6.36 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 32 | 1.0 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 36 | -25.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Platelet count: Week 44 | -7.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 37.48 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 4 | 0.0007 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.01509 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 8 | 0.0087 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.01232 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 12 | 0.0093 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.01312 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 16 | -0.0038 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.02292 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 20 | 0.0162 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.02295 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 24 | 0.0066 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.02353 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 28 | 0.0003 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.01458 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 32 | 0.0314 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 36 | 0.0051 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.02139 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 40 | 0.0063 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.00522 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 44 | 0.0001 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.00017 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 48 | 0.0059 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.00833 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Basophils: Week 52 | -0.0001 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.00008 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 4 | 0.4193 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.63542 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 8 | 0.2385 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.30899 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 16 | 0.1184 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.15326 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 20 | 0.0989 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.13988 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 24 | 0.0698 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.18356 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 28 | 0.0238 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.07607 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 32 | 0.2913 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 36 | 0.0395 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.14069 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 44 | 0.0395 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.02754 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 48 | 0.1645 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.10537 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Eosinophils: Week 52 | 0.0390 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.00136 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 4 | -0.2606 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.01499 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 8 | -0.4114 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.49299 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 12 | -0.2552 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.57253 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 16 | -0.2009 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.40885 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 20 | -0.3649 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5871 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 24 | -0.3050 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.58684 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 28 | -0.2517 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.50673 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Lymphocytes: Week 40 | -0.4961 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.05108 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 12 | 0.0536 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.01924 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 16 | 0.0148 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.00684 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 20 | -0.0307 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.11217 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 24 | -0.0310 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.04098 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 32 | 0.0410 Giga cells per Liter (10^9 cells/L) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 44 | -0.0110 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0269 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Monocytes: Week 48 | 0.0492 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.04132 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 4 | -0.1626 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.16602 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 8 | 0.4712 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.43005 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Neutrophils: Week 12 | 0.4876 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.20136 |
Secondary
Change From Baseline in Hemoglobin (Hgb)
Blood samples were collected from all participants for measurement of Hgb values in g/dL. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Hgb results of participants with intercurrent events were excluded from the summary.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Hemoglobin (Hgb) | Week 2 | -0.15 grams per Liter | Standard Deviation 0.636 |
| Participants Requiring Dialysis (D) | Change From Baseline in Hemoglobin (Hgb) | Week 4 | 0.5 grams per Liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 40 | 0.10 grams per Liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 44 | -0.80 grams per Liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 48 | -0.10 grams per Liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 2 | 0.55 grams per Liter | Standard Deviation 0.071 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 4 | 0.15 grams per Liter | Standard Deviation 1.485 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 8 | 0.30 grams per Liter | Standard Deviation 1.131 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 20 | 0.20 grams per Liter | Standard Deviation 0.707 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 24 | 0.35 grams per Liter | Standard Deviation 1.061 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 28 | 0.30 grams per Liter | Standard Deviation 1.273 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 32 | 1.10 grams per Liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 36 | 0.60 grams per Liter | Standard Deviation 0.566 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 12 | 0.45 grams per Liter | Standard Deviation 0.636 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 52 | 0.60 grams per Liter | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Hemoglobin (Hgb) | Week 16 | -0.40 grams per Liter | Standard Deviation 1.414 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Systolic and diastolic blood pressure (BP) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 2 | 11.5 millimeters of mercury (mmHg) | Standard Deviation 9.19 |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 20 | 8.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 32 | 20.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 36 | 16.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 40 | 10.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 44 | 7.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 52 | 4.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 2 | 3.5 millimeters of mercury (mmHg) | Standard Deviation 2.12 |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 4 | 19.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 12 | -4.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 16 | 5.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 20 | 4.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 24 | 16.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 28 | 6.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 32 | 8.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 36 | 11.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 4 | 9.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 12 | 0.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 16 | 2.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 24 | 25.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 28 | 17.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 8 | 8.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 40 | 2.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 44 | 11.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 52 | 1.0 millimeters of mercury (mmHg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 8 | 6.0 millimeters of mercury (mmHg) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 24 | -4.5 millimeters of mercury (mmHg) | Standard Deviation 10.61 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 44 | 4.5 millimeters of mercury (mmHg) | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 28 | 4.0 millimeters of mercury (mmHg) | Standard Deviation 8.49 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 16 | -8.5 millimeters of mercury (mmHg) | Standard Deviation 2.12 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 28 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 19.8 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 32 | 7.0 millimeters of mercury (mmHg) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 32 | 20.0 millimeters of mercury (mmHg) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 20 | -7.5 millimeters of mercury (mmHg) | Standard Deviation 9.19 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 36 | 2.5 millimeters of mercury (mmHg) | Standard Deviation 14.85 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 36 | 5.0 millimeters of mercury (mmHg) | Standard Deviation 4.24 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 40 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 28.28 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 40 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 5.66 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 44 | -5.5 millimeters of mercury (mmHg) | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 48 | 4.0 millimeters of mercury (mmHg) | Standard Deviation 29.7 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 48 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 52 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 16.97 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 2 | -8.0 millimeters of mercury (mmHg) | Standard Deviation 11.31 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 2 | -7.5 millimeters of mercury (mmHg) | Standard Deviation 3.54 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 52 | -6.0 millimeters of mercury (mmHg) | Standard Deviation 1.41 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 4 | 2.5 millimeters of mercury (mmHg) | Standard Deviation 14.85 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 8 | -3.0 millimeters of mercury (mmHg) | Standard Deviation 2.83 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 4 | 3.5 millimeters of mercury (mmHg) | Standard Deviation 7.78 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 12 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 1.41 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 8 | -0.5 millimeters of mercury (mmHg) | Standard Deviation 16.26 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 16 | -8.0 millimeters of mercury (mmHg) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 24 | -7.0 millimeters of mercury (mmHg) | Standard Deviation 2.83 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Week 20 | -10.0 millimeters of mercury (mmHg) | Standard Deviation 9.9 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Week 12 | -9.5 millimeters of mercury (mmHg) | Standard Deviation 7.78 |
Secondary
Change From Baseline in Weight
Weight readings in kilogram (kg) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 2 | -1.00 kilograms (Kg) | Standard Deviation 0.141 |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 20 | 2.20 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 28 | 1.70 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 44 | 1.50 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 52 | 1.30 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 4 | -1.80 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 8 | -2.40 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 12 | 1.20 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 16 | -0.50 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 24 | 2.00 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 32 | 1.00 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 36 | 0.20 kilograms (Kg) | — |
| Participants Requiring Dialysis (D) | Change From Baseline in Weight | Week 40 | 0.80 kilograms (Kg) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 48 | 2.90 kilograms (Kg) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 12 | 1.00 kilograms (Kg) | Standard Deviation 0.566 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 36 | 0.95 kilograms (Kg) | Standard Deviation 1.768 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 24 | 0.45 kilograms (Kg) | Standard Deviation 0.212 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 16 | 0.60 kilograms (Kg) | Standard Deviation 0.283 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 28 | 0.80 kilograms (Kg) | Standard Deviation 0.99 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 20 | 0.70 kilograms (Kg) | Standard Deviation 0.849 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 44 | 1.85 kilograms (Kg) | Standard Deviation 0.495 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 52 | 2.70 kilograms (Kg) | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 2 | -0.70 kilograms (Kg) | Standard Deviation 0.566 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 40 | 0.95 kilograms (Kg) | Standard Deviation 1.061 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 4 | -0.25 kilograms (Kg) | Standard Deviation 1.485 |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 32 | 1.90 kilograms (Kg) | — |
| Participants Not Yet Requiring Dialysis (ND) | Change From Baseline in Weight | Week 8 | 0.40 kilograms (Kg) | Standard Deviation 0.141 |
Secondary
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Daprodustat dose was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for Hgb between 10 to 12 g/dL. Dose change values of daprodustat from starting dose at each study time point were calculated as dose level at indicated time point minus starting dose at Day 1 (Baseline).
Time frame: Day 1 (Baseline), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 20 | 0 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 24 | 0 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 44 | -4 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 28 | -2 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 12 | -2 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 32 | -6 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 2 | 0 milligrams | Standard Deviation 0 |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 36 | -4 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 16 | 0 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 40 | -4 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 8 | -6 milligrams | — |
| Participants Requiring Dialysis (D) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 4 | 0 milligrams | — |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 40 | -2 milligrams | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 48 | -1 milligrams | — |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 20 | -0.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 44 | -1 milligrams | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 2 | -1 milligrams | Standard Deviation 1.41 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 4 | -0.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 8 | -0.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 12 | -0.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 16 | -0.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 24 | -0.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 28 | -0.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 32 | 0 milligrams | — |
| Participants Not Yet Requiring Dialysis (ND) | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Week 36 | -1 milligrams | Standard Deviation 1.41 |
Secondary
Daprodustat Dose at Each Study Time Point
Mean and standard deviation of daprodustat dose received by participants at each study time point has been presented.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 20 | 6.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 8 | 0.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 24 | 6.00 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 36 | 2.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 28 | 4.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 12 | 4.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 32 | 0.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 4 | 6.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 40 | 2.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 16 | 6.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 44 | 2.0 milligrams | — |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Week 2 | 6.0 milligrams | Standard Deviation 0 |
| Participants Requiring Dialysis (D) | Daprodustat Dose at Each Study Time Point | Baseline (Day 1) | 6.0 milligrams | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 44 | 1.0 milligrams | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 48 | 1.0 milligrams | — |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Baseline (Day 1) | 2.0 milligrams | Standard Deviation 0 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 36 | 1.0 milligrams | Standard Deviation 1.41 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 2 | 1.0 milligrams | Standard Deviation 1.41 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 4 | 1.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 8 | 1.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 12 | 1.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 16 | 1.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 20 | 1.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 24 | 1.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 28 | 1.5 milligrams | Standard Deviation 0.71 |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 32 | 2.0 milligrams | — |
| Participants Not Yet Requiring Dialysis (ND) | Daprodustat Dose at Each Study Time Point | Week 40 | 0.0 milligrams | Standard Deviation 0 |
Secondary
Maximum Plasma Concentration (Cmax) of Daprodustat
Blood samples were collected for the plasma concentrations of daprodustat from which pharmacokinetic (PK) parameters were determined. Mean and standard deviation of daprodustat Cmax at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis).
Time frame: Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose
Population: The analysis was performed on the All Pharmacokinetic Set that included all participants in the Safety analysis who had at least 1 non-missing PK assessment (non-quantifiable values will be considered as non-missing values).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Requiring Dialysis (D) | Maximum Plasma Concentration (Cmax) of Daprodustat | 115.047 Nanograms per milliliters (ng/mL) | Standard Deviation 3.854 |
| Participants Not Yet Requiring Dialysis (ND) | Maximum Plasma Concentration (Cmax) of Daprodustat | 19.447 Nanograms per milliliters (ng/mL) | Standard Deviation 10.77 |
Secondary
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
Number of participants who required daprodustat dose adjustments form the starting dose were assessed. Data were categorized for number of participants who required no dose change (0 times) to 10 times and \>10 times dose adjustments during the study.
Time frame: Up to Week 52
Population: Safety Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 5 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 2 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 6 times | 1 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 8 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 7 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 3 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 9 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 1 time | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 10 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 4 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | >10 times | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | No dose change (0 time) | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | >10 times | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | No dose change (0 time) | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 1 time | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 2 times | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 3 times | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 4 times | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 5 times | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 6 times | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 8 times | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 9 times | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 10 times | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | 7 times | 0 Participants |
Secondary
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Number of participants with Hgb values above, below, and within the target range (10 to 12 g/dL) were assessed. Baseline assessment was defined as the last non-missing value prior to the start date and time of the study drug (Day 1). Hgb results of participants with intercurrent events were excluded from the summary.
Time frame: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 2 | Within Target Range | 2 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 4 | Below Target Range | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Baseline (Day 1) | Above Target Range | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 2 | Below Target Range | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 2 | Above Target Range | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 4 | Above Target Range | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Baseline (Day 1) | Below Target Range | 0 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 4 | Within Target Range | 1 Participants |
| Participants Requiring Dialysis (D) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Baseline (Day 1) | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Baseline (Day 1) | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 2 | Above Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 2 | Within Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 2 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 4 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 4 | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 4 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 8 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 8 | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 8 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 12 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 12 | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 12 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 16 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 16 | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 16 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 20 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 20 | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 20 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 24 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 28 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 28 | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 28 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 32 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 32 | Within Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 48 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 32 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 36 | Above Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 36 | Within Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 40 | Within Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 40 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 44 | Within Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 44 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 48 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 52 | Above Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 52 | Within Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 52 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 24 | Within Target Range | 2 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 24 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 36 | Below Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 40 | Above Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 44 | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Week 48 | Within Target Range | 1 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Baseline (Day 1) | Above Target Range | 0 Participants |
| Participants Not Yet Requiring Dialysis (ND) | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Baseline (Day 1) | Within Target Range | 2 Participants |
Secondary
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
Blood samples were collected for the plasma concentrations of daprodustat and metabolites from which PK parameters were determined. Mean and standard deviation of raw daprodustat and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401) at steady state at pre-dose obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis).
Time frame: Pre-dose on Week 2
Population: All Pharmacokinetic Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Requiring Dialysis (D) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2487818 | 0.869 Nanograms per milliliters (ng/mL) | Standard Deviation 0.137 |
| Participants Requiring Dialysis (D) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2506104 | 10.55 Nanograms per milliliters (ng/mL) | Standard Deviation 3.18 |
| Participants Requiring Dialysis (D) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2391220 | 6.540 Nanograms per milliliters (ng/mL) | Standard Deviation 2.206 |
| Participants Requiring Dialysis (D) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2531398 | 2.490 Nanograms per milliliters (ng/mL) | Standard Deviation 0.184 |
| Participants Requiring Dialysis (D) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2506102 | 3.040 Nanograms per milliliters (ng/mL) | Standard Deviation 0.424 |
| Participants Requiring Dialysis (D) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2531401 | 11.25 Nanograms per milliliters (ng/mL) | Standard Deviation 1.48 |
| Participants Requiring Dialysis (D) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | Daprodustat | 0.4995 Nanograms per milliliters (ng/mL) | Standard Deviation 0.3698 |
| Participants Not Yet Requiring Dialysis (ND) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2531401 | 0.127 Nanograms per milliliters (ng/mL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | Daprodustat | NA Nanograms per milliliters (ng/mL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2391220 | NA Nanograms per milliliters (ng/mL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2487818 | NA Nanograms per milliliters (ng/mL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2506102 | NA Nanograms per milliliters (ng/mL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2506104 | 0.143 Nanograms per milliliters (ng/mL) | — |
| Participants Not Yet Requiring Dialysis (ND) | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | GSK2531398 | NA Nanograms per milliliters (ng/mL) | — |