Bio-Equivalency of 2 Treatment Schedules in HD Patients Clinical Trial
Official title:
Anaemia Correction in Haemodialyzed Patients - Comparative Analysis of Two Erythropoietin Stimulating Agents Schedules
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
Currently available ESAs include epoetin alfa, epoetin beta, and darbepoetin. Epoetin alfa
and beta have been designed to resemble closely the endogenous molecule and have similar
pharmacokinetics. They are considered "short-acting" in comparison to darbepoetin, a
second-generation molecule with a prolonged half-life, which is considered "long-acting."
European and American Best Practice Guidelines (EBPG) recommend preferential subcutaneous
(SC) twice- to thrice-weekly epoetin administration. There is a great deal of evidence that
once-weekly SC administration of epoetin beta to be equally efficient and well tolerated in
HD patients, even in those requiring high weekly epoetin doses. 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.
The trial is designed according to the Guidelines for studies testing the equivalence of
different treatment regimens , and will be conducted with the provisions of the Declaration
of Helsinki and Tokio as amended in Venice (1983).
This is a multicenter (2 centers), prospective, open-label, parallel, controlled trial of
therapy equivalence.
The total observation period is of 80 weeks:
- The baseline phase (pre-therapeutic intervention) - 12 weeks;
- The first study phase of therapeutical intervention - 48 weeks: each the two groups of
patients will receive anaemia treatment according to the Romanian Best Practice
Guidelines either with epoetinum beta or with darbepoetinum;
- The second study phase of therapeutical intervention - 24 weeks: the patients from the
epoetinum beta group will be switched to darbepoetinum. The anaemia treatment will
continue according to the Romanian Best Practice Guidelines, using the recommended
conversion factor of 200 (Romanian Best Practice Guidelines, NKF-DOQI 2006, Revised
EBPG).
300 haemodialyzed patients will be enrolled.
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