Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epogen · 2 trials · 2 indications
If AUC0-48 cannot be calculated then AUC from time of dose administration to the time of the last measurable concentration (AUC0-t) will be used as the primary measure.
| Arm | Type | Description |
|---|---|---|
| Epoetin Hospira | EXPERIMENTAL | Epoetin Hospira |
| Epogen (Amgen) | ACTIVE_COMPARATOR | Epogen (Amgen) |
| Arm A: Epoetin Hospira administered IV for three doses | EXPERIMENTAL | - |
| Arm B: Epogen administered IV for three doses | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Epoetin Hospira | BIOLOGICAL | Variable dose |
| Epogen (Amgen) | BIOLOGICAL | Variable dose |
| Epogen | DRUG | IV dose 3 times a week |
Inclusion Criteria: 1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities 2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) treatment for at least 4...
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Epogen is used for the treatment of anemia associated with chronic renal failure and chronic kidney disease in patients requiring hemodialysis. It is administered intravenously to patients receiving epoetin maintenance treatment. Epogen is currently in Phase 3 clinical development for these indications.
Epogen is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is being studied for use in patients with chronic renal failure and chronic kidney disease who require hemodialysis.
Epogen is in Phase 3 clinical development. A Phase 3 study, NCT01473407, has been completed with 612 participants. This study compared intravenous Epogen to epoetin alfa in patients with chronic kidney disease and chronic renal failure requiring hemodialysis.
Epogen has been studied in two completed clinical trials. NCT01473407 was a Phase 3 study with 612 participants comparing Epogen to epoetin alfa in patients with chronic kidney disease and chronic renal failure. NCT01170078 was a Phase 1 study with 107 participants in chronic renal failure patients.
Epogen is a form of epoetin alfa. Clinical trials have compared Epogen to epoetin alfa from Amgen to evaluate their effects when administered intravenously in patients with chronic renal failure requiring hemodialysis and receiving epoetin maintenance treatment.