Early Administration of L-carnitine in Hemodialysis Patients

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Complication of Hemodialysis; Hyperthyroidism Treated or Under Control

Treatments: Drug: L-Carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT00322322

P050316

Details and patient eligibility

About

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.

Full 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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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110 participants in 1 patient group

1

Experimental group

Description:

L-Carnitine

Treatment:

Drug: L-Carnitine