Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02791763 | Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia | PHASE3 | COMPLETED | 355 | — | — | Jun 6, 2016 | Oct 26, 2018 | May 18, 2021 | 56 | Japan |
The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 1 to 4 mg tablets of GSK1278863 | DRUG | 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 tablet | DRUG | 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 pegol | DRUG | 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. |
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 Kid...