Anaemia Correction in Haemodialyzed Patients - Comparative Analysis of Two Erythropoietin Stimulating Agents Schedules
Status:
Withdrawn
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
Several recent reports support the efficacy of once every-other-week epoetinum administration
in the maintenance phase of the anaemia treatment in predialysis, haemodialysis and in
peritoneal dialysis CKD patients.
However, there are studies suggesting that in HD patients receiving SC short-acting ESA
therapy, ESA efficacy decreases when the dosing is extended from thrice-weekly to once-weekly
administration. When every-2-week administration of long-acting ESAs is extended to every 4
weeks, efficacy either remains stable or decreases incrementally. The GAIN trial (Gain
effectiveness in Anemia treatment with NeoRecormon®) was designed to compare anemia
management with epoetin beta, epoetin alpha or darbepoetin alpha in HD patients. An interim
analysis of data from 1005 stable HD patients suggested that switching to epoetin beta from
either epoetin alpha or darbepoetin alpha resulted in improved efficacy and a 20% dose
reduction in SC epoetin beta.
The aim of the study is to compare two schedules of anaemia treatment in HD patients using
two different erythropoietic stimulating agents (epoetinum beta vs darbepoetinum) with
respect to the efficacy in anaemia correction and to the haemoglobin (Hb) level stability.
This is a multicenter (2 centers), prospective, open-label, parallel, controlled trial of
therapy equivalence
Phase:
Phase 4
Details
Lead Sponsor:
Anemia Working Group Romania
Collaborators:
Dr Carol Davila Teaching Hospital of Nephrology Romanian Renal Registry