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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Renal Anemia; Regular Dialysis Treatment
• Intervention / Treatment: Drug: Epoetin

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.

• Study Type: Interventional
• Enrollment: 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Department of Nephrology and Dialysis, General Hospital Sveti Duh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hemoglobin level

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: General Hospital Sveti Duh
• Investigators: Principal Investigator: Slobodan Milutinovic, M.D., Ph.D., Department of Nephrology and Dialysis, General Hospital Sveti Duh, Zagreb, Croatia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Study Completion: April 1, 1997

Study Registration Dates

• First Submitted: May 4, 2006
• First Submitted That Met QC Criteria: May 4, 2006
• First Posted (Estimate): May 5, 2006

Study Record Updates

• Last Update Posted (Estimate): July 21, 2006
• Last Update Submitted That Met QC Criteria: July 20, 2006
• Last Verified: May 1, 2006

More Information

Terms related to this study

• Keywords: Epoetin alfa; Renal anemia; Epoetin omega; Comparative efficacy trial
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hematinics; Epoetin Alfa
• Other Study ID Numbers: Epo-Comp-00-01