Conditions: Anemia Kidney Failure
Keywords: Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 407
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

Detailed description:

Arms:
arm 1: Erythropoietin(EPO)-naive BIW arm 2: EPO-naive QW arm 3: EPO QW arm 4: EPO Q2W

Interventions: intervention 1: Dynepo (Epoetin delta) intervention 2: Dynepo intervention 3: Dynepo intervention 4: Dynepo
Intervention descriptions: intervention 1: subcutaneous, BIW for 24 weeks intervention 2: subcutaneous, QW for 24 weeks intervention 3: subcutaneous, QW for 24 weeks intervention 4: subcutaneous, Q2W for 24 weeks

Protocol document: