Early Administration of L-carnitine in Hemodialysis Patients
Primary Purpose
Complication of Hemodialysis, Hyperthyroidism Treated or Under Control
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
L-Carnitine
Sponsored by
About this trial
This is an interventional treatment trial for Complication of Hemodialysis focused on measuring L-carnitine supplementation, Hemodialysis, Anaemia, Erythropoietin responsiveness
Eligibility 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
Sites / Locations
- Assistance Publique Hopitaux de Paris
- HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
L-Carnitine
Outcomes
Primary Outcome Measures
Resistance index to erythropoietin
Resistance index to erythropoietin
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.
Secondary Outcome Measures
Acylcarnitine/carnitine ratio measured quarterly
Acylcarnitine/carnitine ratio measured quarterly
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
Predialysis hypotension 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
SF 36 physical and total score at inclusion and at the end of the study
Lipid profile, measured quarterly
Lipid profile, measured quarterly
HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
Albuminemia measured quarterly
Albuminemia measured quarterly
c reactive protein measured quarterly
c reactive protein measured quarterly
Full Information
NCT ID
NCT00322322
First Posted
May 3, 2006
Last Updated
May 3, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00322322
Brief Title
Early Administration of L-carnitine in Hemodialysis Patients
Official Title
Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Hemodialysis, Hyperthyroidism Treated or Under Control
Keywords
L-carnitine supplementation, Hemodialysis, Anaemia, Erythropoietin responsiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
L-Carnitine
Intervention Type
Drug
Intervention Name(s)
L-Carnitine
Intervention Description
L-Carnitine
Primary Outcome Measure Information:
Title
Resistance index to erythropoietin
Description
Resistance index to erythropoietin
Time Frame
during de study
Title
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Description
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Time Frame
during the study
Secondary Outcome Measure Information:
Title
Acylcarnitine/carnitine ratio measured quarterly
Description
Acylcarnitine/carnitine ratio measured quarterly
Time Frame
during the study
Title
Number of red blood cells transfusion per patient during the study, data collected monthly
Description
Number of red blood cells transfusion per patient during the study, data collected monthly
Time Frame
during the study
Title
Predialysis hypotension per patient during the study, data collected monthly
Description
Predialysis hypotension per patient during the study, data collected monthly
Time Frame
during the study
Title
SF 36 physical and total score at inclusion and at the end of the study
Description
SF 36 physical and total score at inclusion and at the end of the study
Time Frame
during the study
Title
Lipid profile, measured quarterly
Description
Lipid profile, measured quarterly
Time Frame
during the study
Title
HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
Description
HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
Time Frame
during the study
Title
Albuminemia measured quarterly
Description
Albuminemia measured quarterly
Time Frame
during the study
Title
c reactive protein measured quarterly
Description
c reactive protein measured quarterly
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucile Mercadal, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Paris
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30408788
Citation
Mercadal L, Tezenas du Montcel S, Chonchol MB, Debure A, Depreneuf H, Servais A, Bassilios N, Assogba U, Allouache M, Prie D. Effects of L-Carnitine on Mineral Metabolism in the Multicentre, Randomized, Double Blind, Placebo-Controlled CARNIDIAL Trial. Am J Nephrol. 2018;48(5):349-356. doi: 10.1159/000494338. Epub 2018 Nov 8.
Results Reference
derived
Learn more about this trial
Early Administration of L-carnitine in Hemodialysis Patients
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