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

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