Conditions: Anemia Chronic Kidney Disease (CKD)
Keywords: erythropoietin alfa CKD 5d
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 435
Healthy volunteers: no

Brief summary:
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Detailed description:
This is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease (CKD).

Arms:
arm 1: HX575, recombinant human epoetin alfa arm 2: US-licensed recombinant human epoetin alfa

Interventions: intervention 1: HX575 epoetin alfa intervention 2: US-licensed epoetin alfa
Intervention descriptions: intervention 1: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL. intervention 2: Solution for subcutaneous injection.

Protocol document: