Early Administration of L-carnitine in Hemodialysis Patients

Phase 3

Completed

• Conditions: Hyperthyroidism Treated or Under Control; Complication of Hemodialysis
• Interventions: Drug: L-Carnitine

• Registration Number: NCT00322322
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2006-05-03
• Study First Submitted QC: 2006-05-03
• Study First Posted: 2006-05-05
• Study Start: 2006-06
• Status Verified: 2007-03
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2011-05-03
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	L-Carnitine	L-Carnitine

Primary Outcome Measures

Name	Time	Method
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.	during the study	Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Resistance index to erythropoietin	during de study	Resistance index to erythropoietin

Secondary Outcome Measures

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

Trial Locations

Locations (2)

HOPITAL LA PITIE SALPETRIERE, service de Néphrologie; 🇫🇷 Paris, France

Assistance Publique Hopitaux de Paris; 🇫🇷 Paris, France