DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: General Hospital Sveti Duh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Disease; Renal Anemia; Regular Dialysis Treatment

Intervention: Epoetin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: General Hospital Sveti Duh

Official(s) and/or principal investigator(s):
Slobodan Milutinovic, M.D., Ph.D., Principal Investigator, Affiliation: Department of Nephrology and Dialysis, General Hospital Sveti Duh, Zagreb, Croatia

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.

Clinical Details

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

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

Primary outcome: Hemoglobin level

Secondary outcome:

Average weekly epoetin dose

Time to achieve hemoglobin level of 10 g/dl

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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: January 1997
Last updated: July 20, 2006

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017