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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00456235
Other study ID # I06024
Secondary ID
Status Completed
Phase Phase 4
First received April 3, 2007
Last updated April 16, 2013
Start date September 2006
Est. completion date September 2011

Study information

Verified date April 2007
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority France : AFSSAPS
Study type Interventional

Clinical Trial 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 the curve (AUC) of mycophenolic acid (MPA). It involves a multicentre phase IV trial with direct individual benefit.

A population of 130 liver transplant patients at 2 to 10 years post-transplant, showing significant clinical ICN side effects and being given bitherapy by ICN +MMF will be included and randomised 1:1 in two arms:

- Arm 1: progressive interruption of ICN after obtaining an AUC of MPA of 50 mg.h/l, followed by MMF monotherapy with dose adjustment based on the AUC of MPA,

- Arm 2: continuation of the ICN+MMF bitherapy without MMF therapeutic drug monitoring.

The main judgement criterion will be the incidence of acute rejection in the 2 groups at 6 months. The secondary judgment criterion will be the evaluation of the benefit of stopping ICN on the side effects caused by these drugs.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date September 2011
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Mycophénolate Mofétil

Ciclosporine A

Tacrolimus


Locations

Country Name City State
France CHU de Besançon Besancon
France CHU de Bordeaux Bordeaux
France CHU de Caen Caen
France Hôpital Beaujon Clichy
France Hôpital Henri Mondor Creteil
France CHU de Grenoble Grenoble
France CHU de Lille Lille
France Hôpital Edouard Herriot Lyon
France CHU de Marseille Marseille
France CHU de Montpellier Montpellier
France CHU de Nice Nice
France Hôpital Cochin Paris
France Hôpital Saint Antoine Paris
France CHU de Rennes Rennes
France CHU de Strasbourg Strasbourg
France CHU de Toulouse Toulouse
France Hôpital Paul Brousse Villejuif

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of biopsy proven acute rejection treated 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). 6 months Yes
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