The phase II trial was conducted to assess safety, pharmacodynamics and pharmacokinetics of Hematide in hemodialysis patients with stable baseline hemoglobin (Hgb) levels between 10 and 12.5 g/dL on previous Epoetin Alfa therapy. The endpoints were Hgb and reticulocyte levels, Hematide dose adjustments and red blood cell transfusions.
The results from this maintenance-switch trial in patients previously treated with three-times weekly Epoetin Alfa demonstrated that mean Hgb levels were maintained following a switch to once-monthly treatments with Hematide at an appropriate dosing regimen.
“These data are encouraging and show that patients can be switched from a regimen of EPO three-times weekly to once monthly Hematide in a controlled fashion where hemoglobin levels were maintained within 1 g/dL of baseline at an appropriate dosing regimen,” said Anatole Besarab, director of Clinical Research at Henry Ford Hospital.
Affymax believes that the data warrant further investigation and it is preparing for phase III clinical trials in patients on dialysis and not on dialysis. The company is currently in discussions with the FDA on the design of this phase III program.