Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epoetin alfa 3 times weekly/once weekly · 1 trial · 1 indication
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.
| Arm | Type | Description |
|---|---|---|
| TIW: Epoetin alfa 3 injections Weekly/Once Weekly | EXPERIMENTAL | Participants will be administered with epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU) |
| QW: Epoetin alfa once weekly | EXPERIMENTAL | Participants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU). |
| Q2W: Epoetin alfa once every two weeks | EXPERIMENTAL | Participants will be administered with epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU). |
| Name | Type | Description |
|---|---|---|
| Epoetin alfa 3 times weekly /once weekly | DRUG | Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks) |
| Epoetin alfa once weekly | DRUG | Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks). |
| Epoetin alfa once every two weeks | DRUG | Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks). |
Inclusion Criteria: * Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory * Require support of an erythropoieti...