Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epoetin alfa RB · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Epoetin alfa RB | ACTIVE_COMPARATOR | - |
| Epoetin alfa DT | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Epoetin alfa RB | DRUG | Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb. |
| Epoetin alfa DT | DRUG | Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb. |
Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin al...
Epoetin alfa RB is an investigational small molecule developed by Amgen Inc. (ticker AMGN) for nephrology. It is being studied in patients with chronic kidney disease receiving hemodialysis, specifically for the treatment of anemia. It remains in clinical development and is not described as approved.
Epoetin alfa RB is being studied for the treatment of anemia in patients with chronic kidney disease who are receiving hemodialysis. Its Phase 3 trial enrolled adults 18 years and older of all sexes and excluded healthy volunteers. The program is focused on nephrology.
Epoetin alfa RB targets EPOR, the erythropoietin receptor, and acts as an agonist at that receptor. EPOR agonism is the mechanism under study in its nephrology program for anemia in chronic kidney disease patients on hemodialysis.
Epoetin alfa RB is being developed by Amgen Inc., which trades under the ticker AMGN. Amgen is the sponsor behind the Phase 3 nephrology program evaluating the asset in anemia among chronic kidney disease patients receiving hemodialysis.
Epoetin alfa RB is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. The asset is investigational and is not described as FDA approved.
Epoetin alfa RB has been evaluated in the Phase 3 trial NCT00146224, titled Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis. That completed trial enrolled 420 patients, was randomized, double blind, and used an active control.