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darbepoetin alfa SF · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| darbepoetin alfa SF | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| darbepoetin alfa SF | DRUG | Frequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL |
Inclusion Criteria: * Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis * Anemic * Currently on erythropoietic therapy * Controlled hypertension * Clinically stable
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Darbepoetin alfa SF is an investigational small molecule developed by Amgen Inc. (ticker AMGN) for kidney disease. It is being studied in chronic kidney disease and reached Phase 3 clinical development. It is an erythropoietin receptor agonist.
Darbepoetin alfa SF is being developed for chronic kidney disease. The Phase 3 study enrolled adults 18 years and older with kidney disease, including chronic kidney disease. It is an investigational agent and is not described as approved for any use.
Darbepoetin alfa SF targets EPOR, the erythropoietin receptor. It acts as an agonist at this receptor. The EPOR target places it in the erythropoietin receptor agonist class.
Amgen Inc., which trades under the ticker AMGN, is the developer of darbepoetin alfa SF. The company is studying the agent in nephrology, specifically for kidney disease.
Darbepoetin alfa SF is in Phase 3 clinical development. It is an investigational drug and is not described as FDA approved. The Phase 3 trial has been completed.
Darbepoetin alfa SF has been studied in one Phase 3 trial, NCT00093977, titled Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease. The trial is completed and enrolled 1,100 participants aged 18 years and older.