NCT00322322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 4, 2011

Status Verified

March 1, 2007

Enrollment Period

4 years

First QC Date

May 3, 2006

Last Update Submit

May 3, 2011

Conditions

Complication of HemodialysisHyperthyroidism Treated or Under Control

Keywords

L-carnitine supplementationHemodialysisAnaemiaErythropoietin responsiveness

Outcome Measures

Primary Outcomes (2)

  • Resistance index to erythropoietin

    Resistance index to erythropoietin

    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.

    during the study

Secondary Outcomes (8)

  • Acylcarnitine/carnitine ratio measured quarterly

    during the study

  • Number of red blood cells transfusion per patient during the study, data collected monthly

    during the study

  • Predialysis hypotension per patient during the study, data collected monthly

    during the study

  • SF 36 physical and total score at inclusion and at the end of the study

    during the study

  • Lipid profile, measured quarterly

    during the study

  • +3 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

L-Carnitine

Drug: L-Carnitine

Interventions

L-CarnitineDRUG

L-Carnitine

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assistance Publique Hopitaux de Paris

Paris, 75004, France

Location

HOPITAL LA PITIE SALPETRIERE, service de Néphrologie

Paris, 75013, France

Location

Related Publications (3)

  • 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.

    PMID: 39498822DERIVED

  • Nishioka 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.

    PMID: 36472884DERIVED

  • 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.

    PMID: 30408788DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Lucile Mercadal, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2006

First Posted

May 5, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 4, 2011

Record last verified: 2007-03

Locations

FR(2)