Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:October 2012
End Date:September 2014
Contact:Amgen Call Center
Phone:866-572-6436

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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. This is a multicenter, single-arm, open-label study in which hemodialysis
subjects treated with epoetin alfa will first be converted to peginesatide, and then
converted back to epoetin alfa. The primary endpoint is the mean hemoglobin during the
evaluation period.


This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether
subjects 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 subjects treated with epoetin alfa 3 times a week
(TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24
weeks, these subjects 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.

Key Inclusion Criteria:

- Receiving hemodialysis 3 times a week

- Receiving epoetin alfa IV 3 times a week

- Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening

Key Exclusion Criteria:

- Systemic hematologic disease

- Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening
We found this trial at
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Meridian, ID
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