Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis Patients:Results of Efficacy Trial
Information source: General Hospital Sveti Duh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease; Renal Anemia; Regular Dialysis Treatment
Intervention: Epoetin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: General Hospital Sveti Duh Official(s) and/or principal investigator(s): Slobodan Milutinovic, M.D., Ph.D., Principal Investigator, Affiliation: Department of Nephrology and Dialysis, General Hospital Sveti Duh, Zagreb, Croatia
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.
Clinical Details
Official title: Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: Hemoglobin level
Secondary outcome: Average weekly epoetin doseTime to achieve hemoglobin level of 10 g/dl
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Nephrology and Dialysis, General Hospital Sveti Duh, Zagreb 10000, Croatia
Additional Information
Starting date: January 1997
Last updated: July 20, 2006
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