Peginesatide

• Peginesatide Overview
• Clinical Trials - Chronic Kidney Disease
  • Development Pipeline
• Clinical Trials - PRCA
• Takeda Collaboration
• Glossary

Clinical Trials - Chronic Kidney Disease

Affymax has conducted Phase 3 clinical trials of peginesatide (formerly known as Hematide™) to treat anemia in patients with chronic kidney disease (CKD). The Phase 3 program included four open-label, randomized controlled clinical trials involving a total of approximately 2,600 CKD patients, including those on dialysis and not on dialysis. Two trials in non-dialysis patients, called PEARL 1 and 2, were designed to evaluate the safety and efficacy of peginesatide compared to darbepoetin alfa in correcting anemia and maintaining hemoglobin in a corrected range over time. In dialysis patients previously-treated with EPO, two trials, called EMERALD 1 and 2, evaluated the safety and efficacy of peginesatide and its ability to maintain hemoglobin levels in a corrected range compared to epoetin alfa or epoetin beta when patients are switched from either of these epoetins to peginesatide. Preliminary top-line results from the Phase 3 clinical program were announced in June 2010 (click here for press release). Analysis of efficacy and safety for all studies was based on assessments to the comparator drugs. The primary efficacy endpoint was the mean change in hemoglobin from baseline. The hemoglobin target range is 11-12 g/dL for studies in non-dialysis patients and 10-12 g/dL for studies in dialysis patients. In all studies, peginesatide was dosed once every four weeks while comparator drugs were dosed in accordance with their respective product labels. The median duration of follow-up for patients on study drug in the four trials was 1.3 years. Assessment of safety included a composite cardiovascular endpoint from a pooled safety database.

EMERALD 1 & 2

These trials included approximately 1,600 patients on dialysis who were previously-treated with epoetin alfa or epoetin beta. The trials were designed to evaluate the safety and efficacy of once-monthly peginesatide and its ability to maintain hemoglobin levels in a corrected range compared to epoetin alfa or epoetin beta when patients are switched from either of these epoetins to peginesatide.

PEARL 1 & 2 

These trials included approximately 950 non-dialysis patients. The studies were designed to evaluate the safety and efficacy of once-monthly peginesatide compared to darbepoetin alfa in correcting anemia and maintaining hemoglobin in a corrected range over time.