Phase 3 Study of Peginesatide for CRF Dialysis Patients with Anemia
Affymax and Takeda announced additional data from two Phase 3 studies, EMERALD 1 and 2, of peginesatide (formerly known as Hematide) for the treatment of patients with chronic renal failure on dialysis with anemia. The EMERALD trials were open-label, randomized, active-controlled clinical studies that involved over 1,600 dialysis patients. The studies included patients who were on hemodialysis for ≥3 months and were being treated with either IV epoetin alfa (≥8 weeks) in the EMERALD 1 trial, or treated with IV or subcutaneous epoetin alfa or beta (≥8 weeks) in the EMERALD 2 trial. Patients were randomized to be given either once-monthly peginesatide or epoetin 1–3 times a week. The primary efficacy endpoint for both studies was the comparison of the mean change in hemoglobin (Hb) levels from baseline to the evaluation period across both treatment groups. In both Phase 3 trials, peginesatide had similar results to epoetin in maintaining Hb levels within target range (between 10–12g/dL).
Peginesatide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent.
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