Early Administration of L-carnitine in Hemodialysis Patients

Complication of Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322322
• Other study ID #: P050316
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2006
• Last updated: May 3, 2011
• Start date: June 2006
• Est. completion date: June 2010

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Hemodialysis
• Hyperthyroidism
• Hyperthyroidism Treated or Under Control

Intervention

Drug:
• L-Carnitine
L-Carnitine

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Paris	Paris
France	HOPITAL LA PITIE SALPETRIERE, service de Néphrologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resistance index to erythropoietin	Resistance index to erythropoietin	during de study	Yes
Primary	Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.	Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.	during the study	Yes
Secondary	Acylcarnitine/carnitine ratio measured quarterly	Acylcarnitine/carnitine ratio measured quarterly	during the study	Yes
Secondary	Number of red blood cells transfusion per patient during the study, data collected monthly	Number of red blood cells transfusion per patient during the study, data collected monthly	during the study	Yes
Secondary	Predialysis hypotension per patient during the study, data collected monthly	Predialysis hypotension per patient during the study, data collected monthly	during the study	Yes
Secondary	SF 36 physical and total score at inclusion and at the end of the study	SF 36 physical and total score at inclusion and at the end of the study	during the study	Yes
Secondary	Lipid profile, measured quarterly	Lipid profile, measured quarterly	during the study	Yes
Secondary	HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance	HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance	during the study	Yes
Secondary	Albuminemia measured quarterly	Albuminemia measured quarterly	during the study	Yes
Secondary	c reactive protein measured quarterly	c reactive protein measured quarterly	during the study	Yes