Anaemia
Conditions
Keywords
Renal Anemia, Japanese, chronic kidney disease, Peritoneal dialysis, GSK1278863, Non-dialysis
Brief summary
This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 286 Japanese ND and 50 PD subjects with renal anemia. The study will consist of three cohorts. Cohort 1 and Cohort 3 will consist of ND subjects (Erythropoiesis-Stimulating Agent \[ESA\] users and ESA non-users) randomized to receive GSK1278863 or epoetin beta pegol in a ratio of 1:1. PD subjects will be enrolled into Cohort 2 and will receive GSK1278863. This study consists of a 4-week screening phase, a 52-week treatment phase (including primary efficacy evaluation period \[Weeks 40 to 52\]), and a 4-week follow-up phase following the treatment phase. The primary objective of this study is to demonstrate non-inferiority of GSK1278863 to epoetin beta pegol based on mean hemoglobin (Hgb) during the primary efficacy evaluation period in ND subjects. ESA non-users from Cohort 1 will be excluded from the primary efficacy analysis. Study results will be used as pivotal study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.
Interventions
DRUG1 to 4 mg tablets of GSK1278863
7.0 millimeters (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of GSK1278863 as active ingredient, to be orally administered once daily.
DRUG6 mg GSK1278863 tablet
9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily.
DRUGEpoetin beta pegol
An injectable formulation containing 25 micrograms µg, 50 µg, 75 µg, 100 µg, 150 µg, 200 µg, or 250 µg of epoetin beta pegol per syringe (0.3 mL), supplied as a glass syringe prefilled with epoetin beta pegol solution (clear colorless to pale yellow). Epoetin beta pegol will be subcutaneously administered once every 2 or 4 weeks.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age (at the time of informed consent): \>=20 years of age * Screening verification only: Stage of chronic kidney disease (CKD) (ND subjects only): CKD stages 3, 4, and 5 defined by estimated glomerular filtration rate (eGFR) using the Japanese Society of Nephrology-Chronic Kidney Disease Initiatives (JSN-CKDI) formula * Dialysis: * Not on dialysis for at least 12 weeks prior to screening (ND subjects) * On peritoneal dialysis (PD subjects) * Use of ESA: * ESA non-users: Have not used ESAs for 8 weeks prior to screening * ESA users: Have used the same ESA for 8 weeks prior to screening. However, in the ND subjects, the dose of darbepoetin alfa or epoetin beta pegol must be stable (administered once every 4 weeks and up to one-step dose change during 8 weeks prior to screening). * Hgb: Determined at the site using an Hgb analyzer * ESA non-users: \>=8.0 g/dL and \<11.0 g/dL * ESA users: \>=9.0 g/dL and \<=13.0 g/dL * Iron parameters: Ferritin \>100 nanograms per milliliters (ng/mL) or transferrin saturation (TSAT) \>20% (screening verification only) * Gender (screening verification only): Female or male. Females: Not pregnant \[demonstrated to be negative for human chorionic gonadotropin (hCG) in urine or serum\], not breast-feeding, and meet at least one of the following: 1. Females of non-childbearing potential are defined as follows: * Pre-menopausal with at least one of the following and no plans to utilize assisted reproductive techniques (e.g., in vitro fertilization or donor embryo transfer): * History of bilateral tubal ligation or salpingectomy * History of hysteroscopic tubal occlusion and postoperatively documented bilateral tubal obstruction * History of hysterectomy * History of bilateral oophorectomy * Postmenopausal defined as: females 60 years of age or older or ; In females \<60 years of age, 12 months of spontaneous amenorrhea (in questionable cases a blood sample with postmenopausal follicle stimulating hormone \[FSH\] and estradiol concentrations is confirmatory \[specified reference ranges\]). Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the most effective contraception methods if they wish to continue their HRT during the study. Otherwise they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Females of childbearing potential must agree to comply with one of the contraception methods listed as requirements in GSK Listing of Most Effective Contraceptive Methods for Females of Childbearing Potential from 28 days prior to the first dose of study medication until the completion of the follow-up visit (for subjects randomized to the GSK1278863 group) or 7 weeks after the last dose of study treatment (for subjects randomized to the Epoetin beta pegol group). * Informed consent: Written informed consent, including adherence to the requirements and conditions specified in the consent form and the protocol, must be obtained from each subject as specified in Protocol.
Exclusion criteria
Chronic kidney disease (CKD)-related criteria * Dialysis * Cohort 1 and Cohort 3: Start or plan to initiate dialysis during the study * Cohort 2: Plan to stop peritoneal dialysis or start hemodialysis during the study * Kidney transplant: Planned living-related kidney transplant during the study Anemia-related criteria * Aplasia: History of bone-marrow hypoplasia or pure red cell aplasia * Other causes of anemia: pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes * Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within 8 weeks prior to screening or during a period from screening to Day 1. Cardiovascular disease-related criteria * Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack: Diagnosed within 8 weeks prior to screening or during a period from screening to Day 1. * Heart failure: Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system * QT interval corrected for heart rate (QTc) (screening verification only): QTc \>500 milliseconds (msec) or QTc \>530 msec in subjects with bundle branch block Note: QT interval corrected using the Bazett's formula (QTcB) will be used, and Electrocardiogram (ECG) can be mechanically or manually read. Other disease-related criteria * Liver disease (if any of the following occurs): * (Screening verification only) Alanine transaminase (ALT) \>2 times upper limit of normal (ULN) * (Screening verification only) Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%) * Current unstable active liver or biliary disease (generally defined by the onset of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, persistent jaundice, or cirrhosis) Note: Stable liver disease (including asymptomatic gallstones, chronic hepatitis B/C, or Gilbert's syndrome) is acceptable if the subject otherwise meets entry criteria.. * Malignancy: History of malignancy within 2 years prior to screening, or currently receiving treatment for cancer, (PD subjects only) complex renal cystic \>3 centimeters (cm) (II F, III or IV based on the Bosniak classification) Note (ND subjects and PD subjects): The only exception is squamous cell or basal cell carcinoma of the skin that has been definitively treated \>=8 weeks before screening. * In the opinion of the investigator, Hgb increase to the target range (11.0-13.0 g/dL) is medically risky. Concomitant medication and other study treatment-related criteria * Iron: Planned use of intravenous iron during the screening phase or during a period from Day 1 to Week 4 Note: Oral iron is acceptable. However, the same dose regimen must be used throughout the screening phase and from Day 1 to Week 4. Antihyperphosphatemic agents containing iron (e.g., ferric citrate hydrate) are also acceptable only if used for at least 12 weeks prior to screening. However, they must be continued throughout the screening phase from Day 1 to Week 4. * Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product or epoetin beta pegol * Drugs and supplements: Use or planned use of any prescription or non-prescription drugs or dietary supplements that are prohibited during the study period (prohibited medications: strong inducers and inhibitor of Cytochrome P450 2C8 \[CYP2C8\]) * Prior investigational product exposure: Use of an investigational agent within 30 days or five half lives of the investigational agent (whichever is longer) * Prior treatment with GSK1278863: Any prior treatment with GSK1278863 for a treatment duration of \>30 days General health-related criteria * Other conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator (or subinvestigator) considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Weeks 40 to 52 | The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period were summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period. |
| Change From Baseline in Hgb at Week 4 in ND Participants | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at Week 4 in ND participants is presented. |
| Change From Baseline in Hgb at Week 4 in PD Participants | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at week 4 in PD participants is presented. |
| Number of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Number of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Daprodustat Dose Level by Visit in ND Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
| Epoetin Beta Pegol Dose Level by Visit in ND Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | Dose of epoetin beta pegol at a scheduled visit was converted to dose per 4 weeks when the dose frequency was every 2 weeks. Epoetin beta pegol dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
| Daprodustat Dose Level by Visit in PD Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | Daprodustat dose level at each assessment visit for PD participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
| Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants | Up to Week 52 | The duration (in days) of treatment interruption due to Hgb \>13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb \>13 g/dL. |
| Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants | Up to Week 52 | The duration (in days) of treatment interruption due to Hgb \>13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb \>13 g/dL. |
| Number of Dose Adjustments in ND Participants | Up to Week 52 | Number of dose adjustments in ND participants is presented. |
| Number of Dose Adjustments in PD Participants | Up to Week 52 | Number of dose adjustments in PD participants is presented. |
| Hgb Values at Each Assessment Visit in ND Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Hgb values at each assessment visit for ND participants is presented. |
| Hgb Values at Each Assessment Visit in PD Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Hgb values at each assessment visit for PD participants is presented. |
| Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in ND participants is presented. |
| Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in PD participants is presented. |
| Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Number of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
| Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Percentage of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
| Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Number of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
| Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Percentage of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
| Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Weeks 40 to 52 | Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52). |
| Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in PD Participants | Weeks 40 to 52 | Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52). |
| Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants | Up to week 52 | The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb \>= 11.0 g/dL were excluded in this summary. |
| Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants | Up to week 52 | The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb \>= 11.0 g/dL were excluded in this summary. |
| Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL | Up to week 52 | Number of ND participants who had an Hgb level of less than 7.5 g/dL is presented. |
| Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL | Up to week 52 | Percentage of ND participants who had an Hgb level of less than 7.5 g/dL is presented. |
| Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL | Up to week 52 | Number of PD participants who had an Hgb level of less than 7.5 g/dL is presented. |
| Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL | Up to week 52 | Percentage of PD participants who had an Hgb level of less than 7.5 g/dL is presented. |
| Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Up to week 52 | Number of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
| Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Up to week 52 | Percentage of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
| Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Up to week 52 | Number of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
| Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Up to week 52 | Percentage of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
| Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL | Up to week 52 | Number of ND participants who had an Hgb level of more than 13.0 g/dL is presented. |
| Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL | Up to week 52 | Percentage of ND participants who had an Hgb level of more than 13.0 g/dL is presented. |
| Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL | Up to week 52 | Number of PD participants who had an Hgb level of more than 13.0 g/dL is presented. |
| Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL | Up to week 52 | Percentage of PD participants who had an Hgb level of more than 13.0 g/dL is presented. |
| Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants | Up to week 52 | Number of episodes with Hgb level of more than 13.0 g/dL in ND participants is presented. |
| Number of Episodes With Hgb Level of More Than 13.0 g/dL in PD Participants | Up to week 52 | Number of episodes with Hgb level of more than 13.0 g/dL in PD participants is presented. |
| Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants | Up to Week 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in ND participants is presented. |
| Monthly Average Dose of Oral Iron During the Treatment Period in PD Participants | Up to Week 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in PD participants is presented. |
| Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants | Weeks 40 to 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in ND participants is presented. |
| Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in PD Participants | Weeks 40 to 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in PD participants is presented. |
| Number of ND Participants Who Used Oral Iron During the Treatment Period | Up to week 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the treatment period were summarized. |
| Number of PD Participants Who Used Oral Iron During the Treatment Period | Up to week 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the treatment period were summarized. |
| Percentage of ND Participants Who Used Oral Iron During the Treatment Period | Up to week 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the treatment period were summarized. |
| Percentage of PD Participants Who Used Oral Iron During the Treatment Period | Up to week 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the treatment period were summarized. |
| Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | Weeks 40 to 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
| Number of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | Weeks 40 to 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
| Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | Weeks 40 to 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
| Percentage of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | Weeks 40 to 52 | Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
| Change From Baseline in Ferritin in ND Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Change from Baseline in Ferritin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
| Change From Baseline in Ferritin in PD Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Change from Baseline in Ferritin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
| Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Percent change from Baseline in TSAT in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
| Percent Change From Baseline in TSAT in PD Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Percent change from Baseline in TSAT in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
| Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | The percentage of ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period. |
| Percent Change From Baseline in Hepcidin in PD Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Percent change from Baseline in Hepcidin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
| Change From Baseline in Serum Iron in ND Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Change from Baseline in serum iron in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
| Change From Baseline in Serum Iron in PD Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Change from Baseline in serum iron in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
| Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Change from Baseline in TIBC in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
| Change From Baseline in TIBC in PD Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Change from Baseline in TIBC in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 1, 2, 3 and 4 hours post dose at Weeks 12 and 24 | Blood samples were collected at indicated timepoints. Pharmacokinetic (PK) parameters of Daprodustat were calculated using non-compartmental method. AUC (0-4) is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant. |
| Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 1, 2, 3 and 4 hours post dose at Weeks 12 and 24 | Blood samples were collected at indicated timepoints. PK parameters of Daprodustat were calculated using non-compartmental method. Cmax is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant. |
| Percent Change From Baseline in Hepcidin in ND Participants | Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 | Percent change from Baseline in Hepcidin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
Countries
Japan
Participant flow
Recruitment details
This was an open-label, active-controlled, parallel-group, multi-center study to compare the efficacy (verification of non-inferiority) and safety of GSK1278863 (daprodustat) versus epoetin beta pegol in Japanese non-dialysis (ND) participants, including an open-label non-comparative cohort of peritoneal dialysis (PD) participants.
Pre-assignment details
A total of 56 centers, contracted in Japan, enrolled and randomized participants. A total of 455 participants were screened and 355 participants were enrolled and randomized in this study.
Participants by arm
| Arm | Count |
|---|---|
| Daprodustat in ND Participants Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks. | 149 |
| Epoetin Beta Pegol in ND Participants Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks. | 150 |
| Daprodustat in PD Participants Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks. | 56 |
| Total | 355 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 12 | 13 | 7 |
| Overall Study | Cancer event | 1 | 3 | 0 |
| Overall Study | Met hemoglobin stopping criteria | 1 | 0 | 0 |
| Overall Study | Needs maintenance/changes in dialysis | 16 | 19 | 5 |
| Overall Study | Participant had renal transplant | 3 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 0 |
Baseline characteristics
| Characteristic | Daprodustat in ND Participants | Epoetin Beta Pegol in ND Participants | Daprodustat in PD Participants | Total |
|---|---|---|---|---|
| Age, Continuous | 68.2 Years STANDARD_DEVIATION 11.57 | 70.3 Years STANDARD_DEVIATION 9.09 | 64.4 Years STANDARD_DEVIATION 9.64 | 68.5 Years STANDARD_DEVIATION 10.45 |
| Race/Ethnicity, Customized Asian- Japanese Heritage | 149 Count of Participants | 150 Count of Participants | 56 Count of Participants | 355 Count of Participants |
| Sex: Female, Male Female | 53 Participants | 58 Participants | 12 Participants | 123 Participants |
| Sex: Female, Male Male | 96 Participants | 92 Participants | 44 Participants | 232 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 149 | 2 / 150 | 0 / 56 |
| other Total, other adverse events | 85 / 149 | 91 / 150 | 41 / 56 |
| serious Total, serious adverse events | 34 / 149 | 43 / 150 | 26 / 56 |
Outcome results
Primary
Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants
The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM).
Time frame: Weeks 40 to 52
Population: Intent to treat (ITT) Population comprised of cohort 1 participants (only erythropoiesis stimulating agent \[ESA\] users) and cohort 3 participants (both ESA users and ESA non-users) who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | 11.97 Grams per deciliter (g/dL) | Standard Error 0.061 |
| Epoetin Beta Pegol in ND Participants | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | 11.86 Grams per deciliter (g/dL) | Standard Error 0.063 |
p-value: <0.000195% CI: [-0.07, 0.28]Mixed model repeated measures (MMRM)
Secondary
Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants
Blood samples were collected at indicated timepoints. Pharmacokinetic (PK) parameters of Daprodustat were calculated using non-compartmental method. AUC (0-4) is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
Time frame: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24
Population: PK Population comprised of all Daprodustat-treated participants from whom PK samples were collected and analyzed. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 35.3199 Hour*nanogram per milliliter | Geometric Coefficient of Variation 38.4 |
| Epoetin Beta Pegol in ND Participants | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 63.0175 Hour*nanogram per milliliter | Geometric Coefficient of Variation 89.8 |
| Daprodustat 4 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 101.9293 Hour*nanogram per milliliter | Geometric Coefficient of Variation 96.5 |
| Daprodustat 6 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 152.4966 Hour*nanogram per milliliter | Geometric Coefficient of Variation 83.2 |
| Daprodustat 8 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 167.6515 Hour*nanogram per milliliter | Geometric Coefficient of Variation 105.9 |
| Daprodustat 12 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 190.0962 Hour*nanogram per milliliter | Geometric Coefficient of Variation 65.9 |
| Daprodustat 18 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 435.6847 Hour*nanogram per milliliter | Geometric Coefficient of Variation 131.7 |
| Daprodustat 24 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants | 404.0567 Hour*nanogram per milliliter | — |
Secondary
Change From Baseline in Ferritin in ND Participants
Change from Baseline in Ferritin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 52, n=87,81 | -42.7 Micrograms per liter (µg/L) |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 28, n=96,93 | -80.1 Micrograms per liter (µg/L) |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 16, n=104,105 | -83.4 Micrograms per liter (µg/L) |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 40, n=88,87 | -56.3 Micrograms per liter (µg/L) |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 4, n=107,109 | -41.4 Micrograms per liter (µg/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 52, n=87,81 | -14.0 Micrograms per liter (µg/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 4, n=107,109 | -29.0 Micrograms per liter (µg/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 40, n=88,87 | -16.0 Micrograms per liter (µg/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 16, n=104,105 | -29.3 Micrograms per liter (µg/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Ferritin in ND Participants | Week 28, n=96,93 | -16.6 Micrograms per liter (µg/L) |
Secondary
Change From Baseline in Ferritin in PD Participants
Change from Baseline in Ferritin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Ferritin in PD Participants | Week 4, n=55 | -36.4 µg/L |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in PD Participants | Week 16, n=51 | -81.8 µg/L |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in PD Participants | Week 28, n=48 | -89.1 µg/L |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in PD Participants | Week 40, n=44 | -74.6 µg/L |
| Daprodustat in ND Participants | Change From Baseline in Ferritin in PD Participants | Week 52, n=43 | -63.6 µg/L |
Secondary
Change From Baseline in Hgb at Week 4 in ND Participants
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at Week 4 in ND participants is presented.
Time frame: Baseline (Day 1) and Week 4
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Hgb at Week 4 in ND Participants | 0.47 g/dL | Standard Deviation 0.878 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb at Week 4 in ND Participants | 0.26 g/dL | Standard Deviation 0.711 |
Secondary
Change From Baseline in Hgb at Week 4 in PD Participants
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at week 4 in PD participants is presented.
Time frame: Baseline (Day 1) and Week 4
Population: Efficacy peritoneal dialysis (PD) Population comprised of PD participants who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Hgb at Week 4 in PD Participants | -0.09 g/dL | Standard Deviation 0.899 |
Secondary
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in ND participants is presented.
Time frame: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 8, n=107,109 | 0.71 g/dL | Standard Deviation 1.122 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 32, n=92,90 | 1.60 g/dL | Standard Deviation 1.371 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 16, n=104,105 | 1.45 g/dL | Standard Deviation 1.376 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 36, n=92,88 | 1.49 g/dL | Standard Deviation 1.265 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 4, n=107,109 | 0.47 g/dL | Standard Deviation 0.878 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 40, n=88,87 | 1.44 g/dL | Standard Deviation 1.371 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 24, n=99,99 | 1.41 g/dL | Standard Deviation 1.346 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 44, n=88,86 | 1.43 g/dL | Standard Deviation 1.435 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 12, n=106,107 | 1.04 g/dL | Standard Deviation 1.352 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 48, n=87,83 | 1.61 g/dL | Standard Deviation 1.35 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 28, n=96,93 | 1.54 g/dL | Standard Deviation 1.375 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 52, n=87,81 | 1.56 g/dL | Standard Deviation 1.527 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 20, n=102,103 | 1.39 g/dL | Standard Deviation 1.33 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 52, n=87,81 | 1.21 g/dL | Standard Deviation 1.432 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 20, n=102,103 | 1.26 g/dL | Standard Deviation 1.336 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 4, n=107,109 | 0.26 g/dL | Standard Deviation 0.711 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 8, n=107,109 | 0.66 g/dL | Standard Deviation 1.109 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 12, n=106,107 | 1.18 g/dL | Standard Deviation 1.384 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 16, n=104,105 | 1.40 g/dL | Standard Deviation 1.495 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 24, n=99,99 | 1.10 g/dL | Standard Deviation 1.295 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 28, n=96,93 | 1.08 g/dL | Standard Deviation 1.151 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 32, n=92,90 | 1.04 g/dL | Standard Deviation 1.299 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 36, n=92,88 | 1.04 g/dL | Standard Deviation 1.294 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 40, n=88,87 | 1.26 g/dL | Standard Deviation 1.304 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 44, n=88,86 | 1.01 g/dL | Standard Deviation 1.131 |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Week 48, n=87,83 | 1.03 g/dL | Standard Deviation 1.172 |
Secondary
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in PD participants is presented.
Time frame: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 28, n=48 | 1.00 g/dL | Standard Deviation 1.317 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 32, n=45 | 1.13 g/dL | Standard Deviation 1.192 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 36, n=45 | 0.95 g/dL | Standard Deviation 1.106 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 40, n=44 | 1.13 g/dL | Standard Deviation 1.227 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 44, n=43 | 0.90 g/dL | Standard Deviation 1.093 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 48, n=43 | 1.08 g/dL | Standard Deviation 1.248 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 4, n=55 | -0.09 g/dL | Standard Deviation 0.899 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 8, n=54 | -0.06 g/dL | Standard Deviation 1.127 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 12, n=52 | 0.44 g/dL | Standard Deviation 1.173 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 16, n=51 | 0.52 g/dL | Standard Deviation 1.295 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 20, n=50 | 0.63 g/dL | Standard Deviation 1.158 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 24, n=49 | 0.74 g/dL | Standard Deviation 1.182 |
| Daprodustat in ND Participants | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Week 52, n=43 | 1.10 g/dL | Standard Deviation 1.226 |
Secondary
Change From Baseline in Serum Iron in ND Participants
Change from Baseline in serum iron in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 4, n=107,109 | 0.5 Micromoles per liter (µmol/L) |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 16, n=104,105 | 0.3 Micromoles per liter (µmol/L) |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 28, n=96,93 | 0.3 Micromoles per liter (µmol/L) |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 40, n=88,87 | 0.9 Micromoles per liter (µmol/L) |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 52, n=87,81 | 0.7 Micromoles per liter (µmol/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 28, n=96,93 | 2.0 Micromoles per liter (µmol/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 4, n=107,109 | -0.8 Micromoles per liter (µmol/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 40, n=88,87 | 1.8 Micromoles per liter (µmol/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 16, n=104,105 | 0.6 Micromoles per liter (µmol/L) |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Serum Iron in ND Participants | Week 52, n=87,81 | 1.1 Micromoles per liter (µmol/L) |
Secondary
Change From Baseline in Serum Iron in PD Participants
Change from Baseline in serum iron in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in PD Participants | Week 16, n=51 | -2.4 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in PD Participants | Week 28, n=48 | -1.0 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in PD Participants | Week 4, n=55 | -1.2 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in PD Participants | Week 40, n=44 | -0.4 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Serum Iron in PD Participants | Week 52, n=43 | 1.0 µmol/L |
Secondary
Change From Baseline in TIBC in PD Participants
Change from Baseline in TIBC in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in TIBC in PD Participants | Week 28, n=48 | 11.0 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in TIBC in PD Participants | Week 40, n=44 | 11.0 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in TIBC in PD Participants | Week 4, n=55 | 6.9 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in TIBC in PD Participants | Week 16, n=51 | 9.5 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in TIBC in PD Participants | Week 52, n=43 | 9.6 µmol/L |
Secondary
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants
Change from Baseline in TIBC in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 16, n=104,105 | 9.9 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 40, n=88,87 | 8.0 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 28, n=96,93 | 9.9 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 52, n=87,81 | 7.8 µmol/L |
| Daprodustat in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 4, n=107,109 | 6.9 µmol/L |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 52, n=87,81 | 0.1 µmol/L |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 4, n=107,109 | 0.5 µmol/L |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 16, n=104,105 | 1.9 µmol/L |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 28, n=96,93 | 1.4 µmol/L |
| Epoetin Beta Pegol in ND Participants | Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants | Week 40, n=88,87 | 0.2 µmol/L |
Secondary
Daprodustat Dose Level by Visit in ND Participants
Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Day 1, n=108 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 4, n=106 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 8, n=106 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 12, n=106 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 16, n=103 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 20, n=100 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 24, n=96 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 28, n=94 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 32, n=92 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 36, n=89 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 40, n=88 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 44, n=88 | 4.0 Milligrams per day (mg/day) |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in ND Participants | Week 48, n=87 | 4.0 Milligrams per day (mg/day) |
Secondary
Daprodustat Dose Level by Visit in PD Participants
Daprodustat dose level at each assessment visit for PD participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Day 1, n=55 | 4.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 4, n=55 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 8, n=52 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 20, n=50 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 24, n=48 | 8.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 28, n=45 | 8.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 32, n=45 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 36, n=45 | 8.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 40, n=44 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 44, n=43 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 48, n=43 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 12, n=52 | 6.0 mg/day |
| Daprodustat in ND Participants | Daprodustat Dose Level by Visit in PD Participants | Week 16, n=51 | 6.0 mg/day |
Secondary
Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants
The duration (in days) of treatment interruption due to Hgb \>13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb \>13 g/dL.
Time frame: Up to Week 52
Population: ITT Population. Only those participants who had Hgb \> 13.0 g/dL of Hemocue were included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat in ND Participants | Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants | 28.0 Days |
| Epoetin Beta Pegol in ND Participants | Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants | 28.0 Days |
Secondary
Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants
The duration (in days) of treatment interruption due to Hgb \>13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb \>13 g/dL.
Time frame: Up to Week 52
Population: Efficacy PD Population. Only those participants who had Hgb \> 13.0 g/dL of Hemocue were included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat in ND Participants | Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants | 28.0 Days |
Secondary
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Dose of epoetin beta pegol at a scheduled visit was converted to dose per 4 weeks when the dose frequency was every 2 weeks. Epoetin beta pegol dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 12, n=105 | 100.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 16, n=104 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 48, n=82 | 100.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Day 1, n=109 | 50.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 4, n=109 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 8, n=107 | 100.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 20, n=100 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 24, n=97 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 28, n=92 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 32, n=90 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 36, n=88 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 40, n=87 | 75.0 Micrograms per 4 weeks |
| Daprodustat in ND Participants | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Week 44, n=84 | 100.0 Micrograms per 4 weeks |
Secondary
Hgb Values at Each Assessment Visit in ND Participants
Hgb values at each assessment visit for ND participants is presented.
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 28, n=96,93 | 11.98 g/dL | Standard Deviation 0.845 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 24, n=99,99 | 11.87 g/dL | Standard Deviation 0.74 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 32, n=92,90 | 12.03 g/dL | Standard Deviation 0.785 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Day 1, n=108,109 | 10.48 g/dL | Standard Deviation 1.14 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 36, n=92,88 | 11.93 g/dL | Standard Deviation 0.73 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 12, n=106,107 | 11.51 g/dL | Standard Deviation 1.024 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 40, n=88,87 | 11.88 g/dL | Standard Deviation 0.735 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 4, n=107,109 | 10.95 g/dL | Standard Deviation 1.122 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 44, n=88,86 | 11.87 g/dL | Standard Deviation 0.868 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 20, n=102,103 | 11.84 g/dL | Standard Deviation 0.909 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 48, n=87,83 | 12.05 g/dL | Standard Deviation 0.896 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 8, n=107,109 | 11.19 g/dL | Standard Deviation 1.092 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 52, n=87,81 | 12.01 g/dL | Standard Deviation 1.003 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 16, n=104,105 | 11.90 g/dL | Standard Deviation 1.091 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 52, n=87,81 | 11.99 g/dL | Standard Deviation 0.93 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 12, n=106,107 | 11.84 g/dL | Standard Deviation 0.88 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 16, n=104,105 | 12.07 g/dL | Standard Deviation 1.073 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 20, n=102,103 | 11.96 g/dL | Standard Deviation 0.82 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Day 1, n=108,109 | 10.68 g/dL | Standard Deviation 1.066 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 4, n=107,109 | 10.94 g/dL | Standard Deviation 1.024 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 24, n=99,99 | 11.80 g/dL | Standard Deviation 0.855 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 28, n=96,93 | 11.83 g/dL | Standard Deviation 0.859 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 32, n=92,90 | 11.80 g/dL | Standard Deviation 0.875 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 36, n=92,88 | 11.81 g/dL | Standard Deviation 0.81 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 40, n=88,87 | 12.00 g/dL | Standard Deviation 0.857 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 44, n=88,86 | 11.75 g/dL | Standard Deviation 0.763 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 48, n=87,83 | 11.80 g/dL | Standard Deviation 0.904 |
| Epoetin Beta Pegol in ND Participants | Hgb Values at Each Assessment Visit in ND Participants | Week 8, n=107,109 | 11.34 g/dL | Standard Deviation 0.905 |
Secondary
Hgb Values at Each Assessment Visit in PD Participants
Hgb values at each assessment visit for PD participants is presented.
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 32, n=45 | 12.07 g/dL | Standard Deviation 0.89 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 36, n=45 | 11.90 g/dL | Standard Deviation 0.839 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 40, n=44 | 12.12 g/dL | Standard Deviation 0.795 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 20, n=50 | 11.54 g/dL | Standard Deviation 0.807 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 24, n=49 | 11.69 g/dL | Standard Deviation 0.816 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Day 1, n=55 | 10.85 g/dL | Standard Deviation 0.964 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 4, n=55 | 10.77 g/dL | Standard Deviation 1.239 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 8, n=54 | 10.83 g/dL | Standard Deviation 1.259 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 12, n=52 | 11.36 g/dL | Standard Deviation 1.097 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 16, n=51 | 11.42 g/dL | Standard Deviation 1.079 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 28, n=48 | 11.95 g/dL | Standard Deviation 1.038 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 44, n=43 | 11.92 g/dL | Standard Deviation 0.824 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 48, n=43 | 12.10 g/dL | Standard Deviation 0.774 |
| Daprodustat in ND Participants | Hgb Values at Each Assessment Visit in PD Participants | Week 52, n=43 | 12.12 g/dL | Standard Deviation 0.699 |
Secondary
Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants
Blood samples were collected at indicated timepoints. PK parameters of Daprodustat were calculated using non-compartmental method. Cmax is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
Time frame: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 17.6522 Nanogram per milliliter | Geometric Coefficient of Variation 36.5 |
| Epoetin Beta Pegol in ND Participants | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 35.0709 Nanogram per milliliter | Geometric Coefficient of Variation 91.2 |
| Daprodustat 4 mg | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 58.6098 Nanogram per milliliter | Geometric Coefficient of Variation 83.2 |
| Daprodustat 6 mg | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 81.1851 Nanogram per milliliter | Geometric Coefficient of Variation 82.6 |
| Daprodustat 8 mg | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 91.0731 Nanogram per milliliter | Geometric Coefficient of Variation 95.4 |
| Daprodustat 12 mg | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 94.1242 Nanogram per milliliter | Geometric Coefficient of Variation 73.3 |
| Daprodustat 18 mg | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 197.9290 Nanogram per milliliter | Geometric Coefficient of Variation 159.6 |
| Daprodustat 24 mg | Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants | 226.0000 Nanogram per milliliter | — |
Secondary
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in ND participants is presented.
Time frame: Weeks 40 to 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants | 967.41 Milligrams | Standard Deviation 1854.896 |
| Epoetin Beta Pegol in ND Participants | Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants | 777.69 Milligrams | Standard Deviation 1639.331 |
Secondary
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in PD Participants
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in PD participants is presented.
Time frame: Weeks 40 to 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in PD Participants | 3038.67 Milligrams | Standard Deviation 6239.034 |
Secondary
Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in ND participants is presented.
Time frame: Up to Week 52
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants | 837.37 Milligrams | Standard Deviation 1209.1 |
| Epoetin Beta Pegol in ND Participants | Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants | 747.04 Milligrams | Standard Deviation 1130.767 |
Secondary
Monthly Average Dose of Oral Iron During the Treatment Period in PD Participants
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in PD participants is presented.
Time frame: Up to Week 52
Population: Efficacy PD Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Monthly Average Dose of Oral Iron During the Treatment Period in PD Participants | 2468.68 Milligrams | Standard Deviation 5418.767 |
Secondary
Number of Dose Adjustments in ND Participants
Number of dose adjustments in ND participants is presented.
Time frame: Up to Week 52
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat in ND Participants | Number of Dose Adjustments in ND Participants | 5.0 Number of dose adjustments |
| Epoetin Beta Pegol in ND Participants | Number of Dose Adjustments in ND Participants | 6.0 Number of dose adjustments |
Secondary
Number of Dose Adjustments in PD Participants
Number of dose adjustments in PD participants is presented.
Time frame: Up to Week 52
Population: Efficacy PD Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat in ND Participants | Number of Dose Adjustments in PD Participants | 5.0 Number of dose adjustments |
Secondary
Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants
Number of episodes with Hgb level of more than 13.0 g/dL in ND participants is presented.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants | 76 Episodes |
| Epoetin Beta Pegol in ND Participants | Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants | 88 Episodes |
Secondary
Number of Episodes With Hgb Level of More Than 13.0 g/dL in PD Participants
Number of episodes with Hgb level of more than 13.0 g/dL in PD participants is presented.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Number of Episodes With Hgb Level of More Than 13.0 g/dL in PD Participants | 43 Episodes |
Secondary
Number of ND Participants by Hgb Change From Baseline Category at Week 4
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >1.0 and <=2.0 | 29 Participants |
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | <=-2.0 | 1 Participants |
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >2.0 | 2 Participants |
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >-1.0 and <=0 | 28 Participants |
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | within +/- 1.0 | 72 Participants |
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >0 and <=1.0 | 43 Participants |
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | over +/- 2.0 | 3 Participants |
| Daprodustat in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >-2.0 and <=-1.0 | 4 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | over +/- 2.0 | 1 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >-2.0 and <=-1.0 | 3 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >-1.0 and <=0 | 33 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >0 and <=1.0 | 56 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >1.0 and <=2.0 | 15 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | >2.0 | 0 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | within +/- 1.0 | 90 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | <=-2.0 | 2 Participants |
Secondary
Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Number of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | 17 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | 11 Participants |
Secondary
Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Number of ND participants who had an Hgb level of less than 7.5 g/dL is presented.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL | 1 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL | 0 Participants |
Secondary
Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
Number of ND participants who had an Hgb level of more than 13.0 g/dL is presented.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL | 49 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL | 52 Participants |
Secondary
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Number of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, n=108,109 | 29 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 8, n=107,109 | 64 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 12, n=106,107 | 78 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 16, n=104,105 | 84 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 20, n=102,103 | 88 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 24, n=99,99 | 86 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 28, n=96,93 | 77 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 32, n=92,90 | 79 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 36, n=92,88 | 79 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 40, n=88,87 | 78 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 44, n=88,86 | 71 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 4, n=107,109 | 43 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 48, n=87,83 | 75 Participants |
| Daprodustat in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 52, n=87,81 | 67 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, n=108,109 | 36 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 4, n=107,109 | 48 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 32, n=92,90 | 67 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 8, n=107,109 | 73 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 48, n=87,83 | 62 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 12, n=106,107 | 85 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 36, n=92,88 | 70 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 16, n=104,105 | 80 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 44, n=88,86 | 68 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 20, n=102,103 | 85 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 40, n=88,87 | 72 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 24, n=99,99 | 85 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 52, n=87,81 | 59 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 28, n=96,93 | 73 Participants |
Secondary
Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Time frame: Weeks 40 to 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | 34 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | 28 Participants |
Secondary
Number of ND Participants Who Used Oral Iron During the Treatment Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the treatment period were summarized.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants Who Used Oral Iron During the Treatment Period | 56 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants Who Used Oral Iron During the Treatment Period | 49 Participants |
Secondary
Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period were summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.
Time frame: Weeks 40 to 52
Population: Modified intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the efficacy evaluation period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daprodustat in ND Participants | Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Non-Responder | 7 Participants |
| Daprodustat in ND Participants | Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Responder | 81 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Non-Responder | 7 Participants |
| Epoetin Beta Pegol in ND Participants | Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Responder | 80 Participants |
p-value: 0.494195% CI: [0.33, 3.04]Regression, Logistic
Secondary
Number of PD Participants by Hgb Change From Baseline Category at Week 4
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: Efficacy PD Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | within +/- 1.0 | 41 Participants |
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | over +/- 2.0 | 1 Participants |
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | <=-2.0 | 0 Participants |
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | >-2.0 and <=-1.0 | 10 Participants |
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | >-1.0 and <=0 | 20 Participants |
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | >0 and <=1.0 | 20 Participants |
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | >1.0 and <=2.0 | 4 Participants |
| Daprodustat in ND Participants | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | >2.0 | 1 Participants |
Secondary
Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Number of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | 11 Participants |
Secondary
Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Number of PD participants who had an Hgb level of less than 7.5 g/dL is presented.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL | 0 Participants |
Secondary
Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
Number of PD participants who had an Hgb level of more than 13.0 g/dL is presented.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL | 28 Participants |
Secondary
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Number of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, n=55 | 28 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 4, n=55 | 25 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 12, n=52 | 32 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 16, n=51 | 32 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 20, n=50 | 38 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 24, n=49 | 36 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 28, n=48 | 39 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 32, n=45 | 34 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 36, n=45 | 36 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 40, n=44 | 34 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 44, n=43 | 33 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 48, n=43 | 36 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 52, n=43 | 38 Participants |
| Daprodustat in ND Participants | Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 8, n=54 | 26 Participants |
Secondary
Number of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Time frame: Weeks 40 to 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | 22 Participants |
Secondary
Number of PD Participants Who Used Oral Iron During the Treatment Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the treatment period were summarized.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daprodustat in ND Participants | Number of PD Participants Who Used Oral Iron During the Treatment Period | 33 Participants |
Secondary
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | within +/- 1.0 | 67 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >0 and <=1.0 | 40 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >-2.0 and <=-1.0 | 4 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >1.0 and <=2.0 | 27 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | <=-2.0 | 1 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >2.0 | 2 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | over +/- 2.0 | 3 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >-1.0 and <=0 | 26 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | over +/- 2.0 | 1 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | within +/- 1.0 | 83 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | <=-2.0 | 2 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >-2.0 and <=-1.0 | 3 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >-1.0 and <=0 | 30 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >0 and <=1.0 | 51 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >1.0 and <=2.0 | 14 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | >2.0 | 0 Percentage of participants |
Secondary
Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Percentage of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | 16 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | 10 Percentage of participants |
Secondary
Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Percentage of ND participants who had an Hgb level of less than 7.5 g/dL is presented.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL | 1 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL | 0 Percentage of participants |
Secondary
Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
Percentage of ND participants who had an Hgb level of more than 13.0 g/dL is presented.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL | 45 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL | 48 Percentage of participants |
Secondary
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Percentage of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 12, n=106,107 | 74 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 16, n=104,105 | 81 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 20, n=102,103 | 86 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 24, n=99,99 | 87 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 28, n=96,93 | 80 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 32, n=92,90 | 86 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 36, n=92,88 | 86 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 40, n=88,87 | 89 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 44, n=88,86 | 81 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 48, n=87,83 | 86 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 52, n=87,81 | 77 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, n=108,109 | 27 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 4, n=107,109 | 40 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 8, n=107,109 | 60 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 52, n=87,81 | 73 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 12, n=106,107 | 79 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 40, n=88,87 | 83 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 16, n=104,105 | 76 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 4, n=107,109 | 44 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 20, n=102,103 | 83 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 44, n=88,86 | 79 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 24, n=99,99 | 86 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, n=108,109 | 33 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 28, n=96,93 | 78 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 48, n=87,83 | 75 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 32, n=92,90 | 74 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 8, n=107,109 | 67 Percentage of Participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 36, n=92,88 | 80 Percentage of Participants |
Secondary
Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Time frame: Weeks 40 to 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | 39 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | 32 Percentage of participants |
Secondary
Percentage of ND Participants Who Used Oral Iron During the Treatment Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the treatment period were summarized.
Time frame: Up to week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants Who Used Oral Iron During the Treatment Period | 52 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants Who Used Oral Iron During the Treatment Period | 45 Percentage of participants |
Secondary
Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
The percentage of ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.
Time frame: Weeks 40 to 52
Population: mITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daprodustat in ND Participants | Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Responder | 92 Percentage of participants |
| Daprodustat in ND Participants | Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Non-Responder | 8 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Responder | 92 Percentage of participants |
| Epoetin Beta Pegol in ND Participants | Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Non-Responder | 8 Percentage of participants |
p-value: 0.494195% CI: [0.33, 3.04]Regression, Logistic
Secondary
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: Efficacy PD Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | <=-2.0 | 0 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | >-2.0 and <=-1.0 | 18 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | >-1.0 and <=0 | 36 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | >0 and <=1.0 | 36 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | within +/- 1.0 | 75 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | over +/- 2.0 | 2 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | >1.0 and <=2.0 | 7 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | >2.0 | 2 Percentage of Participants |
Secondary
Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Percentage of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | 20 Percentage of participants |
Secondary
Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Percentage of PD participants who had an Hgb level of less than 7.5 g/dL is presented.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL | 0 Percentage of participants |
Secondary
Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
Percentage of PD participants who had an Hgb level of more than 13.0 g/dL is presented.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL | 51 Percentage of participants |
Secondary
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Percentage of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Day 1, n=55 | 51 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 4, n=55 | 45 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 8, n=54 | 48 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 20, n=50 | 76 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 24, n=49 | 73 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 28, n=48 | 81 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 32, n=45 | 76 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 36, n=45 | 80 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 40, n=44 | 77 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 44, n=43 | 77 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 48, n=43 | 84 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 52, n=43 | 88 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 12, n=52 | 62 Percentage of Participants |
| Daprodustat in ND Participants | Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit | Week 16, n=51 | 63 Percentage of Participants |
Secondary
Percentage of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Time frame: Weeks 40 to 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | 50 Percentage of participants |
Secondary
Percentage of PD Participants Who Used Oral Iron During the Treatment Period
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the treatment period were summarized.
Time frame: Up to week 52
Population: Efficacy PD Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daprodustat in ND Participants | Percentage of PD Participants Who Used Oral Iron During the Treatment Period | 60 Percentage of participants |
Secondary
Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants
Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).
Time frame: Weeks 40 to 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | 85.44 Percentage of time | Standard Deviation 22.473 |
| Epoetin Beta Pegol in ND Participants | Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | 80.57 Percentage of time | Standard Deviation 25.973 |
Secondary
Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in PD Participants
Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).
Time frame: Weeks 40 to 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daprodustat in ND Participants | Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in PD Participants | 85.73 Percentage of time | Standard Deviation 19.974 |
Secondary
Percent Change From Baseline in Hepcidin in ND Participants
Percent change from Baseline in Hepcidin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 28, n=81,85 | -56.67 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 16, n=86,99 | -55.67 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 40, n=76,80 | -47.77 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 52, n=76,74 | -45.27 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 4, n=99,100 | -49.13 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 52, n=76,74 | 10.13 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 4, n=99,100 | -19.20 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 16, n=86,99 | -3.73 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 28, n=81,85 | 7.61 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Hepcidin in ND Participants | Week 40, n=76,80 | 9.54 Percent change |
Secondary
Percent Change From Baseline in Hepcidin in PD Participants
Percent change from Baseline in Hepcidin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in PD Participants | Week 28, n=39 | -65.37 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in PD Participants | Week 40, n=39 | -67.91 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in PD Participants | Week 52, n=40 | -54.77 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in PD Participants | Week 4, n=53 | -49.79 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Hepcidin in PD Participants | Week 16, n=48 | -62.59 Percent change |
Secondary
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants
Percent change from Baseline in TSAT in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 4, n=107,109 | -12.4 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 16, n=104,105 | -16.3 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 28, n=96,93 | -17.5 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 40, n=88,87 | -11.2 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 52, n=87,81 | -11.7 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 28, n=96,93 | 10.6 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 4, n=107,109 | -5.4 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 52, n=87,81 | 7.0 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 16, n=104,105 | -0.3 Percent change |
| Epoetin Beta Pegol in ND Participants | Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants | Week 40, n=88,87 | 12.5 Percent change |
Secondary
Percent Change From Baseline in TSAT in PD Participants
Percent change from Baseline in TSAT in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Time frame: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Daprodustat in ND Participants | Percent Change From Baseline in TSAT in PD Participants | Week 4, n=55 | -19.2 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in TSAT in PD Participants | Week 16, n=51 | -29.1 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in TSAT in PD Participants | Week 28, n=48 | -22.6 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in TSAT in PD Participants | Week 40, n=44 | -19.5 Percent change |
| Daprodustat in ND Participants | Percent Change From Baseline in TSAT in PD Participants | Week 52, n=43 | -14.7 Percent change |
Secondary
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants
The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb \>= 11.0 g/dL were excluded in this summary.
Time frame: Up to week 52
Population: ITT Population. Only those participants who experienced this event were included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat in ND Participants | Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants | 58.0 Days |
| Epoetin Beta Pegol in ND Participants | Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants | 57.0 Days |
Secondary
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants
The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb \>= 11.0 g/dL were excluded in this summary.
Time frame: Up to week 52
Population: Efficacy PD Population. Only those participants who experienced this event were included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daprodustat in ND Participants | Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants | 84.0 Days |