Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis Patients:Results of Efficacy Trial
Primary Purpose
End Stage Renal Disease, Renal Anemia, Regular Dialysis Treatment
Status
Completed
Phase
Phase 3
Locations
Croatia
Study Type
Interventional
Intervention
Epoetin
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Epoetin alfa, Epoetin omega, Comparative efficacy trial, Renal anemia
Eligibility 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
Sites / Locations
- Department of Nephrology and Dialysis, General Hospital Sveti Duh
Outcomes
Primary Outcome Measures
Hemoglobin level
Secondary Outcome Measures
Average weekly epoetin dose
Time to achieve hemoglobin level of 10 g/dl
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00322413
Brief Title
Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis Patients:Results of Efficacy Trial
Official Title
Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1997 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
General Hospital Sveti Duh
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Renal Anemia, Regular Dialysis Treatment
Keywords
Epoetin alfa, Epoetin omega, Comparative efficacy trial, Renal anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Epoetin
Primary Outcome Measure Information:
Title
Hemoglobin level
Secondary Outcome Measure Information:
Title
Average weekly epoetin dose
Title
Time to achieve hemoglobin level of 10 g/dl
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Slobodan Milutinovic, M.D., Ph.D.
Organizational Affiliation
Department of Nephrology and Dialysis, General Hospital Sveti Duh, Zagreb, Croatia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology and Dialysis, General Hospital Sveti Duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16758521
Citation
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.
Results Reference
result
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Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis Patients:Results of Efficacy Trial
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