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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00322322 |
Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.
Condition | Intervention | Phase |
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Patient Beginning Chronic Hemodialysis for Less Than 1 Month Treated With rHuerythropoietin |
Drug: L-Carnitine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Early Administration of L-Carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo |
Estimated Enrollment: | 110 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2008 |
The first aim of the study is to compare the resistance index to erythropoietin (hemoglobin level / rHuerythropoietin dose) with L-carnitine versus placebo Double blind randomized study evaluating the supplementation with L-carnitine versus placebo in patients beginning chronic hemodialysis for less than 1 month.
Primary outcome to compare rHuerythropoietin resistance index defined as hemoglobin level / rHuEPO dose ratio with L-carnitine and with placebo.
Secondary endpoints to compare acylcarnitine / carnitine ratio, number of red blood cells transfusion, physical status, quality of life, hypotensive episodes, lipid profile, diabetes profile, albuminemia, c reactive protein.
Several variables that influenced primary and secondary endpoints will be included in a multivariate analysis; albuminemia, c reactive protein, iron status, dialysis efficiency, protein intake, lipid intake, treatment with additional vitamins (C, B9, B6), treatment with statins, treatment of predialysis hypotension by midodrine, antihypertensive treatments.
Statistical analysis:
Following analysis in both intention to treat and per protocol analysis:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lucile MERCADAL, MD,PhD | +33 (0) 1 42 17 72 20 | lucile.mercadal@psl.aphp.fr |
France | |
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie | Recruiting |
PARIS, France, 75013 | |
Contact: Lucile Mercadal, MD,PhD + 33 (0) 1 42 17 72 20 lucile.mercadal@psl.aphp.fr | |
Assistance Publique Hopitaux De Paris | Recruiting |
PARIS, France, 75004 | |
Contact: Lucile Mercadal, MD,PhD + 33 (0) 1 42 17 72 20 lucile.mercadal@psl.aphp.fr |
Principal Investigator: | Lucile Mercadal, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P050316 |
Study First Received: | May 3, 2006 |
Last Updated: | March 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00322322 |
Health Authority: | France: Ministry of Health |
L–carnitine supplementation Hemodialysis Anaemia Erythropoietin responsiveness |
Epoetin Alfa Anemia Carnitine |
Vitamin B Complex Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Pharmacologic Actions |