Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis Patients:Results of Efficacy Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa

Conditions
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End Stage Renal Disease, Renal Anemia, Regular Dialysis Treatment

Intervention / Treatment
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* Drug: Epoetin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average weekly epoetin dose |  |  | 
| Time to achieve hemoglobin level of 10 g/dl |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epoetin alfa, Epoetin omega, Comparative efficacy trial, Renal anemia