Japanese drug major Takeda and US drugmaker Affymax have reported positive 12-month data from an ongoing Phase II trial evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anemia associated with chronic kidney disease.
Preliminary data from the trial showed that Hematide administered once every four weeks was well tolerated and maintained mean hemoglobin levels between 11g/dL and 12g/dL in patients with CKD both pre-dialysis and on hemodialysis over a 12-month period. The findings were presented at the 45th ERA-EDTA Congress, in Stockholm, Sweden.
In addition, the companies announced the results of two other studies. One study also assessed safety and tolerability of Hematide in CKD, but only for patients already on hemodialysis and a third presentation detailed data relating to the treatment with Hematide of CKD patients with pure red cell aplasia, a rare but serious condition, where the body produces antibodies to erythropoiesis-stimulating agents and the patient's endogenous erythropoietin. Patients who develop PRCA are usually transfusion-dependent.
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