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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02969655 | A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) | PHASE3 | COMPLETED | 271 | — | — | Nov 21, 2016 | Jul 2, 2018 | Nov 27, 2020 | 50 | Japan |
The mean hemoglobin during the Evaluation Period was estimated by a statistical model.
| Arm | Type | Description |
|---|---|---|
| Daprodustat | EXPERIMENTAL | Subjects will receive oral daprodustat once daily and intravenous (IV) darbepoetin alfa placebo once weekly for 52 weeks |
| Darbepoetin alfa | ACTIVE_COMPARATOR | Subjects will receive IV darbepoetin alfa once weekly and oral daprodustat placebo once daily for 52 weeks |
| Name | Type | Description |
|---|---|---|
| Daprodustat small | DRUG | Available as 7.0 millimeter (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of daprodustat as active ingredient |
| Daprodustat small placebo | DRUG | Available as 7.0 mm round, standard biconvex, white film coated tablets containing no daprodustat |
| Daprodustat large | DRUG | Available as 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of daprodustat as active ingredient |
| Daprodustat large placebo | DRUG | Available as 9.0 mm round, standard biconvex, white film coated tablets containing no daprodustat |
| Darbepoetin alfa | DRUG | Available as 0.5 mL plastic prefilled syringes (PFS) for IV injection each containing 10, 15, 20, 30, 40 or 60 mcg of darbepoetin alfa in a clear and colorless solution. |
| Darbepoetin alfa placebo | DRUG | Available as 0.5 mL plastic PFS for IV injection containing no darbepoetin alfa in a clear and colorless solution. |
Inclusion Criteria * Age (informed consent): \>=20 years of age * Dialysis: On HD or hemodiafiltration (HDF) given three times weekly for at least 12 weeks prior to screening * ESAs: Use of one and the same ESA for 10 weeks prior to screening * ESA dose: Darbepoetin alfa 10 to 60 μg per week, epoet...