Complication of HemodialysisPhase 3NCT00322322
Early Administration of L-carnitine in Hemodialysis Patients
A Phase 3 study testing L-Carnitine in people with Complication of Hemodialysis and Hyperthyroidism Treated or Under Control, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Hemodialysis, Hyperthyroidism Treated or Under Control
- What is being tested?
- L-Carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2006to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Assistance Publique Hopitaux de Paris
Paris, 75004
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
Paris, 75013
About this study
Official title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
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.
Read the 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
- Being tested
- L-Carnitine
- Keywords
- L-carnitine supplementation, Hemodialysis, Anaemia, Erythropoietin responsiveness
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDrug
L-Carnitine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | L-Carnitine Receives: Drug: L-Carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance index to erythropoietin
Resistance index to erythropoietin
Measured: during de study
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.
Measured: during the study
Secondary outcomes (8)
Acylcarnitine/carnitine ratio measured quarterly
Acylcarnitine/carnitine ratio measured quarterly
Measured: during the study
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
Measured: during the study
Predialysis hypotension per patient during the study, data collected monthly
Predialysis hypotension per patient during the study, data collected monthly
Measured: during the study
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
Measured: during the study
Lipid profile, measured quarterly
Lipid profile, measured quarterly
Measured: during the study
HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance
Measured: during the study
Albuminemia measured quarterly
Albuminemia measured quarterly
Measured: during the study
c reactive protein measured quarterly
c reactive protein measured quarterly
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complication of HemodialysisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Lucile Mercadal, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322322
- Sponsor's protocol ID
- P050316
- Status last verified
- Mar 2007
- First submitted
- 3 May 2006
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
PubMed 39498822Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.
PubMed 36472884Mercadal 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.
PubMed 30408788
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
- ClinicalTrials.gov ID
- NCT00322322
- Acronym / sponsor ID
- P050316
- Keywords
- L-carnitine supplementation, Hemodialysis, Anaemia, Erythropoietin responsiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: L-CarnitineL-Carnitine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CarnitineL-Carnitine | Drug | 1 |
Primary outcome
Resistance index to erythropoietin
Time frame: during de study
Resistance index to erythropoietin
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
Time frame: during the study
Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.
8 secondary outcomes
Acylcarnitine/carnitine ratio 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
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
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
Albuminemia measured quarterly
Time frame: during the study
c reactive protein measured quarterly
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
- Derived from this study: PubMed 39498822Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
- Derived from this study: PubMed 36472884Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.
- Derived from this study: PubMed 30408788Mercadal 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.
Related trials for Complication of Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucile Mercadal, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-Carnitine in people with Complication of Hemodialysis and Hyperthyroidism Treated or Under Control, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resistance index to erythropoietin (time frame: during de study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00322322, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2011.