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Early Administration of L-carnitine in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00322322
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE May 3, 2006
First Posted Date  ICMJE May 5, 2006
Last Update Posted Date May 4, 2011
Study Start Date  ICMJE June 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
  • Resistance index to erythropoietin [ Time Frame: during de study ]
    Resistance index to erythropoietin
  • Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. [ Time Frame: during the study ]
    Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2006)
  • Resistance index to erythropoietin
  • Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
  • Acylcarnitine/carnitine ratio measured quarterly [ Time Frame: during the study ]
    Acylcarnitine/carnitine ratio measured quarterly
  • Number of red blood cells transfusion per patient during the study, data collected monthly [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: during the study ]
    SF 36 physical and total score at inclusion and at the end of the study
  • Lipid profile, measured quarterly [ Time Frame: during the study ]
    Lipid profile, measured quarterly
  • HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance [ Time Frame: during the study ]
    HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
  • Albuminemia measured quarterly [ Time Frame: during the study ]
    Albuminemia measured quarterly
  • c reactive protein measured quarterly [ Time Frame: during the study ]
    c reactive protein measured quarterly
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Administration of L-carnitine in Hemodialysis Patients
Official Title  ICMJE Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Complication of Hemodialysis
  • Hyperthyroidism Treated or Under Control
Intervention  ICMJE Drug: L-Carnitine
L-Carnitine
Study Arms  ICMJE Experimental: 1
L-Carnitine
Intervention: Drug: L-Carnitine
Publications * Mercadal L, Tezenas du Montcel S, Chonchol MB, Debure A, Depreneuf H, Servais A, Bassilios N, Assogba U, Allouache M, Prié D. Effects of L-Carnitine on Mineral Metabolism in the Multicentre, Randomized, Double Blind, Placebo-Controlled CARNIDIAL Trial. Am J Nephrol. 2018;48(5):349-356. doi: 10.1159/000494338. Epub 2018 Nov 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2006)
110
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00322322
Other Study ID Numbers  ICMJE P050316
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabelle BRINDEL, Department of Clinical Research of developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lucile Mercadal, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2007

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