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Early Administration of L-Carnitine in Hemodialysis Patients
This study is currently recruiting participants.
Study NCT00322322   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: May 3, 2006   Last Updated: March 13, 2007   History of Changes

May 3, 2006
March 13, 2007
June 2006
 
  • Resistance index to erythropoietin
  • Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Same as current
Complete list of historical versions of study NCT00322322 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Early Administration of L-Carnitine in Hemodialysis Patients
Early Administration of L-Carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

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.

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
Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
  • Patient Beginning Chronic Hemodialysis for Less Than 1 Month
  • Treated With rHuerythropoietin
Drug: L-Carnitine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
110
June 2008
 

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
Both
18 Years and older
No
Contact: Lucile MERCADAL, MD,PhD +33 (0) 1 42 17 72 20 lucile.mercadal@psl.aphp.fr
France
 
NCT00322322
 
P050316
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Lucile Mercadal, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP