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

This study has been completed.
Sponsor:
Information provided by:
General Hospital Sveti Duh
ClinicalTrials.gov Identifier:
NCT00322413
First received: May 4, 2006
Last updated: July 20, 2006
Last verified: May 2006
  Purpose

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 Intervention Phase
End Stage Renal Disease
Renal Anemia
Regular Dialysis Treatment
Drug: Epoetin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa

Resource links provided by NLM:


Further study details as provided by General Hospital Sveti Duh:

Primary Outcome Measures:
  • Hemoglobin level

Secondary Outcome Measures:
  • Average weekly epoetin dose
  • Time to achieve hemoglobin level of 10 g/dl

Estimated Enrollment: 80
Study Start Date: January 1997
Estimated Study Completion Date: April 1997
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322413

Locations
Croatia
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00322413     History of Changes
Other Study ID Numbers: Epo-Comp-00-01
Study First Received: May 4, 2006
Last Updated: July 20, 2006
Health Authority: Croatia: Ministry of Health and Social Care

Keywords provided by General Hospital Sveti Duh:
Epoetin alfa
Epoetin omega
Comparative efficacy trial
Renal anemia

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014