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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
CHU de Besançon
Besançon, France
CHU de Bordeaux
Bordeaux, France
CHU de Caen
Caen, France
Hôpital Beaujon
Clichy, France
Hôpital Henri Mondor
Créteil, 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
...and 7 more locations
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).
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.