Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis Patients:Results of Efficacy Trial
Status:
Completed
Trial end date:
1997-04-01
Target enrollment:
Participant gender:
Summary
The two epoetins, Epoetin alfa, a well established drug to treat renal anemia and Epoetin
Omega, that differs from Epoetin alfa in the sugar moiety of the molecule were compared in
regard of efficacy and safety to treat end stage renal disease anemia. Study hypothesis was
that Epoetin Omega is non-inferior to Epoetin alfa in correcting renal anemia in dialysis
patients. A 12-weeks randomized comparative efficacy study was performed including 77 end
stage renal disease patients (epoetin omega:n=39, epoetin alfa: n=38). In the intent-to-treat
analysis, average weekly difference in hemoglobin versus baseline value was higher in
omega-treated patients: 1.94+-0.81 vs. 1.23+-0.62 g/dl. The unadjusted and adjusted
omega-alfa differences were 0.71 g/dl (95%CI 0.38 to 1.04; p<0.001) and 0.78 g/dl (0.49 to
1.08;p<0.001), respectively. Average weekly epoetin dose was lower in the omega group: 87+-25
vs. 108+-21 IU/kg. The unadjusted and adjusted omega-alfa differences were -21IU/kg (-32 to
-11; p<0.001) and -24IU/kg (-35 to -13; p<0.001), respectively. Epoetins were comparably well
tolerated. In dialysis patients, subcutaneous epoetin omega apparently provides a greater
anti-anemic effect per administered dose (IU) than epoetin alfa.