Status:
COMPLETED
Early Administration of L-carnitine in Hemodialysis Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Complication of Hemodialysis
Hyperthyroidism Treated or Under Control
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 propose...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00322322
Start Date
June 1 2006
End Date
June 1 2010
Last Update
May 4 2011
Active Locations (2)
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1
Assistance Publique Hopitaux de Paris
Paris, France, 75004
2
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
Paris, France, 75013