The trial is intended to generate data for Hematide as an anemia correction therapy in this segment of the chronic renal failure patient population, some of whom may be erythropoiesis stimulating agent (ESA)-naive. This is the first Hematide correction study in the dialysis indication.
The Phase II clinical trial is a randomized, controlled study that is expected to enroll approximately 120 hemodialysis patients who have not had treatment with an ESA in a prior 12 week period.
The primary objective of the trial is to evaluate the safety, efficacy and dose response to Hematide administered once per month. Enrollment in this trial is expected to be completed by the end of 2008.
Arlene Morris, president and CEO of Affymax, said: “This new study is one of several Phase II trials we plan to conduct to evaluate key differentiating attributes and to investigate the versatility of Hematide prior to commercialization, as we pursue our ultimate goal of broad use of the product globally.”