Clinical Trials - PRCA
Affymax is currently conducting a Phase 2 clinical trial of peginesatide (formerly known as Hematide™) to treat anemia in dialysis and non-dialysis patients with pure red cell aplasia (PRCA, anti-erythropoietin antibody-mediated) in Europe. PRCA, a rare autoimmune disorder, occurs when the body produces neutralizing antibodies to the currently marketed recombinant human erythropoietin (EPO), thus suppressing the production of red blood cells by the bone marrow. In contrast, peginesatide, Affymax’s product candidate in development for the treatment of anemia, is a novel synthetic, pegylated peptidic compound with no structural similarities with human EPO.
The open-label, multi-center trial is ongoing in dialysis and non-dialysis CKD patients with PRCA evaluating the effectiveness and safety of peginesatide administered subcutaneously every four weeks. The primary endpoint is the change in hemoglobin from baseline over time. Secondary endpoints include safety and the effectiveness of peginesatide in reducing the frequency of red blood cell transfusions over time.