Early Administration of L-carnitine in Hemodialysis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00322322
• Date of registration: 03/05/2006
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Early Administration of L-carnitine in Hemodialysis Patients
• Scientific title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
• Date of first enrolment: June 2006
• Target sample size: 110
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00322322
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Lucile Mercadal, MD,PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hyperthyroidism Treated or Under Control

Complication of Hemodialysis

Intervention(s)

Drug: L-Carnitine

Primary Outcome(s)

Resistance index to erythropoietin [Time Frame: during de study]

Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. [Time Frame: during the study]

Secondary Outcome(s)

Predialysis hypotension per patient during the study, data collected monthly [Time Frame: during the study]

SF 36 physical and total score at inclusion and at the end of the study [Time Frame: during the study]

c reactive protein measured quarterly [Time Frame: during the study]

Lipid profile, measured quarterly [Time Frame: during the study]

HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance [Time Frame: during the study]

Acylcarnitine/carnitine ratio measured quarterly [Time Frame: during the study]

Albuminemia measured quarterly [Time Frame: during the study]

Number of red blood cells transfusion per patient during the study, data collected monthly [Time Frame: during the study]

Secondary ID(s)

P050316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors