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news.Affymax and Takeda Pharmaceutical Company have announced the results from a open-label, multi-center Phase II clinical trial of Hematide to treat anemia in dialysis and predialysis chronic kidney disease patients with pure red cell aplasia. Results showed that Hematide could restore hemoglobin to the target range in these patients and eliminate the need for red blood cell transfusions in the patients studied.
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This Phase II trial in 10 dialysis and predialysis chronic kidney disease (CKD) patients with pure red cell aplasia (PRCA) evaluated the effectiveness and safety of Hematide administered subcutaneously every four weeks. The primary endpoint was the change in hemoglobin from baseline over time. Secondary endpoints included safety and the effectiveness of Hematide in reducing the frequency of red blood cell transfusions over time.
Results showed that by six months of treatment, median hemoglobin had increased from 9.7g/dL to 11.6g/dL and transfusion requirements were eliminated. Three patients, who had their hemoglobin levels increased with Hematide, improved sufficiently to undergo kidney transplant surgery. Hematide was generally well tolerated. Some adverse events, including bone pain, hypertension, injection site hematoma, and increased blood pressure, were considered possibly related to Hematide.