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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: General Hospital Sveti Duh
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• End stage renal disease

• Regular dialysis treatment

• Renal anemia (hemoglobin<9.0 g/dl)

• Age > 18 years

• Adequate iron stores (TIBC saturation > 20%, ferritin >200)

Exclusion Criteria:

• Signs of bleeding

• Major surgery in previous 60 days

• Hemolysis

• Other causes of anemia

• Cancer

• Inflammatory diseases