Status:
COMPLETED
Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors
Lead Sponsor:
University Hospital, Limoges
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The aim of this project is to determine whether, in liver transplant patients with side effects due to ICN, the use of MMF in monotherapy can be optimised by dose adjustment based on the area under th...
Eligibility Criteria
Inclusion
- Patient with first liver transplantion or retransplantation since more than 6 months: with a post-transplant lapse of time of 2 to 10 years and showing one of the following adverse effects of ICN:
- Renal insufficiency defined by a creatinine clearance \<50ml/mn (calculated or estimated according to the Cockcroft formula)
- Arterial hypertension not controlled by an anti-hypertensive bitherapy
- Diabetes mellitus (fasting glycaemia \>7.0mmol/l), whether treated or not
- Neuromuscular toxicity
- Immunosuppression by cyclosporine or tacrolimus and MMF
- Hepatic biopsy performed within the 6 months preceding the inclusion for the patients with a post-transplant period of \<5 years and in the 12 months preceding the inclusion for patients with a post transplant period of \>5 years.
Exclusion
- Acute rejection within the 6 months preceding the screening
- Previous history of cortico-resistant rejection
- Chronic rejection
- Significant ductopenia (absence of inter-lobule biliary canals in more than 30% of the portal tracts) on the pre-screening biopsy.
- Existence of a pre-transplantation diabetes mellitus.
- Liver transplantation for auto-immune hepatitis or primary sclerosing cholangitis
- Patients transplanted for viral C cirrhosis with reinfection lesions of the transplanted organ, rendering treatment by ribarivine + interferon conceivable in the year following inclusion.
- Counter-indications to MMF (anaemia, leucopenia)
- Immunosuppression by sirolimus, everolimus, azathioprine or corticoids
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00456235
Start Date
September 1 2006
End Date
September 1 2011
Last Update
April 17 2013
Active Locations (17)
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1
CHU de Besançon
Besançon, France, 25030
2
CHU de Bordeaux
Bordeaux, France, 33076
3
CHU de Caen
Caen, France, 14033
4
Hôpital Beaujon
Clichy, France, 92000