AnaemiaPhase 3NCT02791763
Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
A Phase 3 study testing 1 to 4 mg tablets of GSK1278863, 6 mg GSK1278863 tablet and Epoetin beta pegol in people with Anaemia, run by GlaxoSmithKline at 56 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anaemia
- What is being tested?
- 1 to 4 mg tablets of GSK1278863, 6 mg GSK1278863 tablet and Epoetin beta pegol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 56 sitesJapan
- Study dates
- 6 Jun 2016to 26 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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:
- 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.
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
Japan56 sites
GSK Investigational Site
Aichi, 453-8566
GSK Investigational Site
Aichi, 455-8530
GSK Investigational Site
Aichi, 457-8511
GSK Investigational Site
Aichi, 486-8510
GSK Investigational Site
Chiba, 260-8712
GSK Investigational Site
Chiba, 278-0004
GSK Investigational Site
Ehime, 790-0024
GSK Investigational Site
Fukui, 910-8526
GSK Investigational Site
Fukuoka, 802-8555
GSK Investigational Site
Fukuoka, 820-8505
GSK Investigational Site
Fukushima, 963-8052
GSK Investigational Site
Gifu, 500-8523
GSK Investigational Site
Gifu, 500-8717
GSK Investigational Site
Hiroshima, 720-0838
GSK Investigational Site
Hokkaido, 007-0803
GSK Investigational Site
Hokkaido, 060-0033
GSK Investigational Site
Hokkaido, 065-8611
GSK Investigational Site
Hokkaido, 073-0022
GSK Investigational Site
Hokkaido, 073-0196
GSK Investigational Site
Ibaraki, 302-0022
GSK Investigational Site
Ibaraki, 306-0433
GSK Investigational Site
Ibaraki, 310-0015
GSK Investigational Site
Ishikawa, 920-0353
GSK Investigational Site
Ishikawa, 920-8530
GSK Investigational Site
Kagoshima, 890-0073
GSK Investigational Site
Kagoshima, 893-0024
GSK Investigational Site
Kagoshima, 899-5431
GSK Investigational Site
Kanagawa, 210-0852
GSK Investigational Site
Kanagawa, 234-8503
GSK Investigational Site
Kanagawa, 242-0018
GSK Investigational Site
Kanagawa, 251-8550
GSK Investigational Site
Kumamoto, 861-8520
GSK Investigational Site
Kumamoto, 862-8505
GSK Investigational Site
Kyoto, 604-8845
GSK Investigational Site
Kyoto, 611-0041
GSK Investigational Site
Kyoto, 612-8555
GSK Investigational Site
Nagano, 396-8555
GSK Investigational Site
Nagano, 399-8292
GSK Investigational Site
Numakunai, 020-0066
GSK Investigational Site
Ōita, 874-0011
GSK Investigational Site
Osaka, 530-0012
GSK Investigational Site
Osaka, 530-8480
GSK Investigational Site
Osaka, 555-0001
GSK Investigational Site
Osaka, 558-8558
GSK Investigational Site
Osaka, 586-8521
GSK Investigational Site
Osaka, 591-8025
GSK Investigational Site
Saitama, 330-8553
GSK Investigational Site
Saitama, 335-0023
GSK Investigational Site
Shiga, 523-0082
GSK Investigational Site
Shizuoka, 425-8505
GSK Investigational Site
Tokushima, 770-0011
GSK Investigational Site
Tokyo, 141-8625
GSK Investigational Site
Tottori, 683-0002
GSK Investigational Site
Toyama, 932-8503
GSK Investigational Site
Toyama, 937-0042
GSK Investigational Site
Toyama, 938-8502
About this study
Official title: A 52-week, Phase III, Open-label, Multi-center Study to Evaluate Efficacy and Safety of GSK1278863 in Japanese Non-dialysis and Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease
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.
- Conditions
- Anaemia
- Being tested
- 1 to 4 mg tablets of GSK1278863, 6 mg GSK1278863 tablet, Epoetin beta pegol
- Keywords
- Renal Anemia, Japanese, chronic kidney disease, Peritoneal dialysis, GSK1278863, Non-dialysis
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 to 4 mg tablets of GSK1278863Drug
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.
6 mg GSK1278863 tabletDrug
9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily.
Epoetin beta pegolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Daprodustat in ND participants | Experimental | Eligible ND participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams [mg] as recommended) dose once daily for 52 weeks. Receives: Drug: 1 to 4 mg tablets of GSK1278863; Drug: 6 mg GSK1278863 tablet |
| Epoetin beta pegol in ND participants | Active comparator | Eligible ND participants will receive 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. Receives: Drug: Epoetin beta pegol |
| Daprodustat in PD participants | Experimental | Eligible PD participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks. Receives: Drug: 1 to 4 mg tablets of GSK1278863; Drug: 6 mg GSK1278863 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Weeks 40 to 52
Secondary outcomes (65)
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.
Measured: Weeks 40 to 52
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.
Measured: Weeks 40 to 52
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.
Measured: Baseline (Day 1) and Week 4
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.
Measured: Baseline (Day 1) and Week 4
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.
Measured: Baseline (Day 1) and Week 4
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.
Measured: Baseline (Day 1) and Week 4
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.
Measured: Baseline (Day 1) and Week 4
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.
Measured: Baseline (Day 1) and Week 4
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).
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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).
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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).
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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.
Measured: Up to Week 52
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.
Measured: Up to Week 52
Number of Dose Adjustments in ND Participants
Number of dose adjustments in ND participants is presented.
Measured: Up to Week 52
Number of Dose Adjustments in PD Participants
Number of dose adjustments in PD participants is presented.
Measured: Up to Week 52
Hgb Values at Each Assessment Visit in ND Participants
Hgb values at each assessment visit for ND participants is presented.
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Hgb Values at Each Assessment Visit in PD Participants
Hgb values at each assessment visit for PD participants is presented.
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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.
Measured: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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.
Measured: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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.
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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.
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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.
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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.
Measured: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 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 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).
Measured: 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
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).
Measured: Weeks 40 to 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to Week 52
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.
Measured: Up to Week 52
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.
Measured: Weeks 40 to 52
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.
Measured: Weeks 40 to 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Up to week 52
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.
Measured: Weeks 40 to 52
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.
Measured: Weeks 40 to 52
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.
Measured: Weeks 40 to 52
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.
Measured: Weeks 40 to 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
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.
Measured: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24
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.
Measured: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start6 Jun 2016
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791763
- Sponsor's protocol ID
- 201753
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2016
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site.
Publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278Nangaku M, Hamano T, Akizawa T, Tsubakihara Y, Nagai R, Okuda N, Kurata K, Nagakubo T, Jones NP, Endo Y, Cobitz AR. Daprodustat Compared with Epoetin Beta Pegol for Anemia in Japanese Patients Not on Dialysis: A 52-Week Randomized Open-Label Phase 3 Trial. Am J Nephrol. 2021;52(1):26-35. doi: 10.1159/000513103. Epub 2021 Feb 9.
PubMed 33561857
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Phase III, Open-label, Multi-center Study to Evaluate Efficacy and Safety of GSK1278863 in Japanese Non-dialysis and Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02791763
- Acronym / sponsor ID
- 201753
- Conditions
- Anaemia
- Keywords
- Renal Anemia, Japanese, chronic kidney disease, Peritoneal dialysis, GSK1278863, Non-dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daprodustat in ND participants | Experimental | Drug: 1 to 4 mg tablets of GSK1278863, Drug: 6 mg GSK1278863 tabletEligible ND participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams [mg] as recommended) dose once daily for 52 weeks. |
| Epoetin beta pegol in ND participants | Active comparator | Drug: Epoetin beta pegolEligible ND participants will receive 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. |
| Daprodustat in PD participants | Experimental | Drug: 1 to 4 mg tablets of GSK1278863, Drug: 6 mg GSK1278863 tabletEligible PD participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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:
- Use of ESA:
- Hgb: Determined at the site using an Hgb analyzer
Key exclusion criteria (27 listed)
- Chronic kidney disease (CKD)-related criteria
- Dialysis
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 to 4 mg tablets of GSK12788637.0 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. | Drug | Daprodustat in ND participants, Daprodustat in PD participants |
| 6 mg GSK1278863 tablet9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily. | Drug | Daprodustat in ND participants, Daprodustat in PD participants |
| Epoetin beta pegolAn 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. | Drug | Epoetin beta pegol in ND participants |
Primary outcome
Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants
Time frame: 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).
65 secondary outcomes
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)
Time frame: Weeks 40 to 52
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)
Time frame: Weeks 40 to 52
Change From Baseline in Hgb at Week 4 in ND Participants
Time frame: Baseline (Day 1) and Week 4
Change From Baseline in Hgb at Week 4 in PD Participants
Time frame: Baseline (Day 1) and Week 4
Number of ND Participants by Hgb Change From Baseline Category at Week 4
Time frame: Baseline (Day 1) and Week 4
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
Time frame: Baseline (Day 1) and Week 4
Number of PD Participants by Hgb Change From Baseline Category at Week 4
Time frame: Baseline (Day 1) and Week 4
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
Time frame: Baseline (Day 1) and Week 4
Daprodustat Dose Level by Visit in ND Participants
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
Daprodustat Dose Level by Visit in PD Participants
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants
Time frame: Up to Week 52
Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants
Time frame: Up to Week 52
Number of Dose Adjustments in ND Participants
Time frame: Up to Week 52
Number of Dose Adjustments in PD Participants
Time frame: Up to Week 52
Hgb Values at Each Assessment Visit in ND Participants
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Hgb Values at Each Assessment Visit in PD Participants
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Time frame: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Time frame: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 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 ND Participants
Time frame: 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
Time frame: Weeks 40 to 52
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants
Time frame: Up to week 52
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants
Time frame: Up to week 52
Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Time frame: Up to week 52
Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Time frame: Up to week 52
Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Time frame: Up to week 52
Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
Time frame: Up to week 52
Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Time frame: Up to week 52
Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Time frame: Up to week 52
Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Time frame: Up to week 52
Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
Time frame: Up to week 52
Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
Time frame: Up to week 52
Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
Time frame: Up to week 52
Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
Time frame: Up to week 52
Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
Time frame: Up to week 52
Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants
Time frame: Up to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Derived from this study: PubMed 33561857Nangaku M, Hamano T, Akizawa T, Tsubakihara Y, Nagai R, Okuda N, Kurata K, Nagakubo T, Jones NP, Endo Y, Cobitz AR. Daprodustat Compared with Epoetin Beta Pegol for Anemia in Japanese Patients Not on Dialysis: A 52-Week Randomized Open-Label Phase 3 Trial. Am J Nephrol. 2021;52(1):26-35. doi: 10.1159/000513103. Epub 2021 Feb 9.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1 to 4 mg tablets of GSK1278863, 6 mg GSK1278863 tablet and Epoetin beta pegol in people with Anaemia, run by GlaxoSmithKline at 56 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants (time frame: Weeks 40 to 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791763, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.