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NCT Number: NCT00322322

Early Administration of L-carnitine in Hemodialysis Patients

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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Key information

Conditions

Complication of Hemodialysis Anemia Hematologic Diseases Hemic and Lymphatic Diseases Hyperthyroidism Treated or Under Control

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique Hopitaux de Paris, Paris, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-carnitine

Drug

L-Carnitine

Primary outcomes

  1. Resistance index to erythropoietin

    Time frame: during de study

    Resistance index to erythropoietin

  2. 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.

Secondary outcomes

  1. Acylcarnitine/carnitine ratio measured quarterly

    Time frame: during the study

    Acylcarnitine/carnitine ratio measured quarterly

  2. 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

  3. 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

  4. 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

  5. Lipid profile, measured quarterly

    Time frame: during the study

    Lipid profile, measured quarterly

  6. 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

  7. Albuminemia measured quarterly

    Time frame: during the study

    Albuminemia measured quarterly

  8. c reactive protein measured quarterly

    Time frame: during the study

    c reactive protein measured quarterly

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
May 5, 2006
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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