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

Sponsor
General Hospital Sveti Duh (Other)
Overall Status
Completed
CT.gov ID
NCT00322413
Collaborator
(none)
80
Enrollment
1
Location
3
Duration (Months)
27.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa
Study Start Date :
Jan 1, 1997
Study Completion Date :
Apr 1, 1997

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin level []

Secondary Outcome Measures

  1. Average weekly epoetin dose []

  2. Time to achieve hemoglobin level of 10 g/dl []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nephrology and Dialysis, General Hospital Sveti Duh Zagreb Croatia 10000

Sponsors and Collaborators

  • General Hospital Sveti Duh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00322413
Other Study ID Numbers:
  • Epo-Comp-00-01
First Posted:
May 5, 2006
Last Update Posted:
Jul 21, 2006
Last Verified:
May 1, 2006
Keywords provided by , ,
Epoetin alfa
Epoetin omega
Comparative efficacy trial
Renal anemia
Additional relevant MeSH terms:
Kidney Failure, Chronic
Epoetin Alfa

Study Results

No Results Posted as of Jul 21, 2006