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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


Phase 4
18 Years
80 Years
Open (Enrolling)
Both
Liver Transplantation

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Trial Information

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


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of biopsy proven acute rejection treated with corticoids or requiring a re-introduction of ICN in arm 1 -- or an increase of ICN in arm 2 -- 6 months after the interruption of ICN (arm 1) or after randomization (arm 2).

Principal Investigator

Pierre MARQUET, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Limoges

Authority:

France : AFSSAPS

Study ID:

I06024

NCT ID:

NCT00456235

Start Date:

September 2006

Completion Date:

July 2011

Related Keywords:

  • Liver Transplantation

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