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Anaemia Correction in Haemodialyzed Patients - Comparative Analysis of Two Erythropoietin Stimulating Agents Schedules

NCT00551603 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-12-22

No results posted yet for this study

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

Conditions

  • Bio-Equivalency of 2 Treatment Schedules in HD Patients

Interventions

DRUG

switch (epoetinum beta, darbepoetinum)

switching from epoetinum beta once weekly to once-fortnightly darbepoetinum

DRUG

continuation (darbepoetinum)

continuation of the previous darbepoetinum administration schedule

Sponsors & Collaborators

  • Dr Carol Davila Teaching Hospital of Nephrology

    collaborator UNKNOWN

  • Romanian Renal Registry

    collaborator UNKNOWN

  • Anemia Working Group Romania

    lead OTHER

Principal Investigators

  • Liliana Garneata, MD, PhD · Anemia Working Group

  • Gabriel Mircescu, Professor · Anemia Working Group

  • Carmen Barbulescu, MD · "Dr Carol Davila" NephroCare Dialysis Centre

  • Alexandru Ciocalteu, Professor · "IHS" Dialysis Centre "Sf Ioan Nou" Clinical Hospital

  • Daniela Ciortea, MD, PhD · IHS Dialysis Centre, "Sf Ioan Nou" Clinical Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-12-31
Completion
2009-03-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00551603 on ClinicalTrials.gov