Early Administration of L-carnitine in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Complication of Hemodialysis Hyperthyroidism Treated or Under Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

L-Carnitine

Group Type EXPERIMENTAL

L-Carnitine

Intervention Type DRUG

L-Carnitine

Interventions

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L-Carnitine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No