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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322413
• Other study ID #: Epo-Comp-00-01
• Status: Completed
• Phase: Phase 3
• First received: May 4, 2006
• Last updated: July 20, 2006
• Start date: January 1997
• Est. completion date: April 1997

Study information

• Verified date: May 2006
• Source: General Hospital Sveti Duh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Regular Dialysis Treatment
• Renal Anemia

Intervention

Drug:
• Epoetin

Locations

Country	Name	City	State
Croatia	Department of Nephrology and Dialysis, General Hospital Sveti Duh	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Sveti Duh

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

Milutinovic S, Trkulja V. Reduced responsiveness to epoetin at re-exposure after prolonged epoetin-free period in anemic hemodialysis patients with end-stage renal disease. Croat Med J. 2006 Jun;47(3):424-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level
Secondary	Average weekly epoetin dose
Secondary	Time to achieve hemoglobin level of 10 g/dl