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De Novo Administration of Darbepoetin Alfa · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| darbepoetin alfa | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| De Novo Administration of Darbepoetin Alfa | DRUG | Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL |
Inclusion Criteria: - Diagnosis of CKD and not expected to initiate dialysis for the duration of the study - Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min measured by the following modified MDRD (Modification of Diet in Renal Dise...
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De Novo Administration of Darbepoetin Alfa is used for chronic kidney disease (CKD), specifically in patients not receiving dialysis. It is an investigational therapy being developed by Amgen Inc. (AMGN) and is currently in Phase 3 clinical development for this indication.
De Novo Administration of Darbepoetin Alfa is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 3 clinical trials for chronic kidney disease.
De Novo Administration of Darbepoetin Alfa is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with chronic kidney disease.
De Novo Administration of Darbepoetin Alfa has one completed Phase 3 clinical trial, identified as NCT00112008. This trial, titled "Study for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis," enrolled 100 participants with chronic kidney disease and kidney disease.
De Novo Administration of Darbepoetin Alfa is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for chronic kidney disease. The drug has completed one Phase 3 trial, but approval status has not been established.