Early Administration of L-carnitine in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00322322
First received: May 3, 2006
Last updated: May 3, 2011
Last verified: March 2007
  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
Complication of Hemodialysis
Hyperthyroidism Treated or Under Control
Drug: L-Carnitine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Resistance index to erythropoietin [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    Resistance index to erythropoietin

  • Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.


Secondary Outcome Measures:
  • Acylcarnitine/carnitine ratio measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Acylcarnitine/carnitine ratio measured quarterly

  • Number of red blood cells transfusion per patient during the study, data collected monthly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Number of red blood cells transfusion per patient during the study, data collected monthly

  • Predialysis hypotension per patient during the study, data collected monthly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    SF 36 physical and total score at inclusion and at the end of the study

  • Lipid profile, measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Lipid profile, measured quarterly

  • HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance

  • Albuminemia measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Albuminemia measured quarterly

  • c reactive protein measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    c reactive protein measured quarterly


Enrollment: 110
Study Start Date: June 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
L-Carnitine
Drug: L-Carnitine
L-Carnitine
Other Name: L-Carnitine

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

Locations
France
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
Paris, France, 75013
Assistance Publique Hopitaux de Paris
Paris, France, 75004
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

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00322322     History of Changes
Other Study ID Numbers: P050316
Study First Received: May 3, 2006
Last Updated: May 3, 2011
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:
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014