Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322413
Status:
COMPLETED
Last Update Posted:
2006-07-21
First Post:
2006-05-04
Brief Title:
Comparison of Epoetin Alfa and Epoetin Omega in Anemic Dialysis PatientsResults of Efficacy Trial
Sponsor:
General Hospital Sveti Duh
Organization:
General Hospital Sveti Duh
Study Overview
Official Title:
Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis Part II Comparative Trial Versus Epoetin Alfa
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 omegan39 epoetin alfa n38 In the intent-to-treat analysis average weekly difference in hemoglobin versus baseline value was higher in omega-treated patients 194-081 vs 123-062 gdl The unadjusted and adjusted omega-alfa differences were 071 gdl 95CI 038 to 104 p0001 and 078 gdl 049 to 108p0001 respectively Average weekly epoetin dose was lower in the omega group 87-25 vs 108-21 IUkg The unadjusted and adjusted omega-alfa differences were -21IUkg -32 to -11 p0001 and -24IUkg -35 to -13 p0001 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 omegan39 epoetin alfa n38 All patients were anemic Hemoglobin 90 gL treated by regular hemodialysis and without signs of bleeding hemolysis inflammation or history of major surgeryTreatment was started with 50 IUkg 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 194-081 vs 123-062 gdl The unadjusted and adjusted omega-alfa differences were 071 gdl 95CI 038 to 104 p0001 and 078 gdl 049 to 108p0001 respectively Average weekly epoetin dose was lower in the omega group 87-25 vs 108-21 IUkg The unadjusted and adjusted omega-alfa differences were -21IUkg -32 to -11 p0001 and -24IUkg -35 to -13 p0001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None