Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis Patients:Results of Efficacy Trial
Condition: End Stage Renal Disease; Renal Anemia; Regular Dialysis Treatment
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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). All patients were
      anemic (Hemoglobin < 90 g/L), treated by regular hemodialysis and without signs of bleeding,
      hemolysis, inflammation or history of major surgery.Treatment was started with 50 IU/kg body
      weight subcutaneously per week and thereafter adjusted according to the hemoglobin response.
      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.
    

Intervention name(s): Epoetin
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Epoetin alfa; Epoetin omega; Comparative efficacy trial; Renal anemia