Conditions: Anemia
Keywords: Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Detailed description:
This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Arms:
arm 1: Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.

Interventions: intervention 1: Peginesatide intervention 2: Epoetin alfa
Intervention descriptions: intervention 1: All participants will receive peginesatide for the first 24 weeks. intervention 2: All participants converted to epoetin alfa at week 25 for a total of 32 weeks

Protocol document: