Early Administration of L-Carnitine in Hemodialysis Patients - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00322322

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Carnitine

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Resistance index to erythropoietin
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.

Secondary Outcome Measures:

Acylcarnitine/carnitine ratio measured quarterly
Number of red blood cells transfusion per patient during the study, data collected monthly
Predialysis hypotension per patient during the study, data collected monthly
SF 36 physical and total score at inclusion and at the end of the study
Lipid profile, measured quarterly
HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
Albuminemia measured quarterly
c reactive protein measured quarterly

Estimated Enrollment:	110
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2008

Detailed Description:

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:

description of the cohort
comparisons of each evaluated variables between the 2 treatments
ANOVA study for repeated measurements from inclusion to month-12 for Hb / rHuEPO dose to compare the course of the ratio between each group in intention to treat analysis
analysis of the ratio Hb / rHuEPO month by month and taking into account tempera withdrawal

Following analysis in both intention to treat and per protocol analysis:

acylcarnitine / carnitine ratio by ANOVA for repeated data
number of predialysis hypotension by Chi2 test
number of red blood cells transfusion by Chi2 test
SF-36 physical status by comparison of mean
SF-36 total score by comparison of mean
lipid profile by ANOVA for repeated data
HbA1c by ANOVA for repeated data
variables that influenced primary and secondary variables will be analyzed by multivariate analysis
statistical study of clinical events per month

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with less than 1 month on hemodialysis.
Treated with rHuEPO.
Male or female aged of more than 18 years old.
With contraception treatment for women of procreation age.
Having received and understand information.

Exclusion Criteria:

Patients with no need of rHuEPO
Patients with cancer disease
Patients with life expectancy under 6 months
Patients having a proved carnitine deficiency before the start of hemodialysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322322

Contacts

Contact: Lucile MERCADAL, MD,PhD

+33 (0) 1 42 17 72 20

lucile.mercadal@psl.aphp.fr

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Lucile Mercadal, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Study ID Numbers:	P050316
Study First Received:	May 3, 2006
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00322322 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

L–carnitine supplementation
Hemodialysis
Anaemia
Erythropoietin responsiveness

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins
Physiological Effects of Drugs

Micronutrients
Pharmacologic Actions
Carnitine

ClinicalTrials.gov processed this record on November 09, 2009