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Sponsors and Collaborators: |
Anemia Working Group Romania Dr Carol Davila Teaching Hospital of Nephrology Romanian Renal Registry |
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Information provided by: | Anemia Working Group Romania |
ClinicalTrials.gov Identifier: | NCT00551603 |
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
Condition | Intervention | Phase |
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Bio-Equivalency of 2 Treatment Schedules in HD Patients |
Drug: switch (epoetinum beta, darbepoetinum) Drug: continuation (darbepoetinum) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | Anaemia Correction in Haemodialyzed Patients - Comparative Analysis of Two Erythropoietin Stimulating Agents Schedules |
Estimated Enrollment: | 300 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
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1: Experimental
Group Epo will receive anaemia treatment according to the Romanian Best Practice Guidelines recommendation, with once-weekly SC epoetinum beta during the first phase, then will be switched to receive SC once-fortnightly darbepoetinum. Anaemia treatment schedule will continue according to the Romanian Best Practice Guidelines recommendations, with the same dose. A conversion factor of 1:200 will be used.
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Drug: switch (epoetinum beta, darbepoetinum)
switching from epoetinum beta once weekly to once-fortnightly darbepoetinum
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2: Active Comparator
Subjects in the Darbepo Group will receive anaemia treatment according to the Romanian Best Practice Guidelines recommendation, with once-fortnightly or once-monthly darbepoetin SC administration, continuing their previous schedule and will continue their previous schedule of anaemia treatment during the second phase of the study
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Drug: continuation (darbepoetinum)
continuation of the previous darbepoetinum administration schedule
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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 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Liliana Garneata, MD, PhD | +40 722619358 | lilianagarna@yahoo.com |
Romania | |
"Dr Carol Davila" Fresenius NephroCare Dialysis Centre | Recruiting |
Bucharest, Romania, 0107231 | |
Contact: Liliana Garneata, MD, PhD +40722619358 lilianagarna@yahoo.com | |
Sub-Investigator: Carmen Barbulescu, MD | |
IHS Dialysis Centre "Sf Ioan Nou" Clinical Hospital | Recruiting |
Bucharest, Romania | |
Contact: Daniela Ciortea, MD, PhD | |
Principal Investigator: Daniela Ciortea, MD |
Study Director: | Liliana Garneata, MD, PhD | Anemia Working Group |
Study Chair: | Gabriel Mircescu, Professor | Anemia Working Group |
Principal Investigator: | Carmen Barbulescu, MD | "Dr Carol Davila" NephroCare Dialysis Centre |
Study Director: | Alexandru Ciocalteu, Professor | "IHS" Dialysis Centre "Sf Ioan Nou" Clinical Hospital |
Principal Investigator: | Daniela Ciortea, MD, PhD | IHS Dialysis Centre, "Sf Ioan Nou" Clinical Hospital |
Study ID Numbers: | AWG_03_07, 1246/ANM |
Study First Received: | October 29, 2007 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00551603 |
Health Authority: | Romania: National Medicines Agency |
epoetinum beta once-weekly darbepoetinum once-fortnightly anemia correction hemoglobin stability |
Epoetin Alfa Anemia |