Early Administration of L-carnitine in Hemodialysis Patients
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complication of Hemodialysis; Hyperthyroidism Treated or Under Control
Intervention: L-Carnitine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Lucile Mercadal, MD,PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
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.
Clinical Details
Official title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Resistance index to erythropoietinHaemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Secondary outcome: Acylcarnitine/carnitine ratio measured quarterlyNumber 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Assistance Publique Hopitaux de Paris, Paris 75004, France
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie, Paris 75013, France
Additional Information
Starting date: June 2006
Last updated: May 3, 2011
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