Interruption of the Calcineurine Inhibitors (ICN) and Introduction of Mycophenolate Mofetil (MMF) in Liver Transplant Patients With Side Effects Due to ICN: Study of the Reduction of the Risks of Rejection by Mycophenolate Mofetil Therapeutic Drug Monitoring
- 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.
- 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