liver transplant patients suffering adverse effects from treatment with calcineurin inhibitors MedDRA version: 9.1 Level: LLT Classification code 10050434 Term: Prophylaxis against liver transplant rejection MedDRA version: 9.1 Level: LLT Classification code 10054980 Term: Immunosuppressant drug therapy MedDRA version: 9.1 Level: LLT Classification code 10052538 Term: Adverse drug reaction NOS
Conditions
Interventions
Trade Name: Cellcept
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MYCOPHENOLATE MOFETIL
CAS Number: 115007346
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
CHU de Liège, Domaine Universitaire du Sart Tilman
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patient aged 18 years or older 2) Patient has signed informed consent 3) Patient is able to understand the purpose of the trial 4) First liver transplant or retransplant with delay post-LT of 2 to 10 years 5) Transplantee presenting with adverse effects from anticalcineurins: - Kidney insufficiency defined by creatinine clearance 140/90 measured after 10 min rest in laying position - Diabetes (Fasting glycaemia > 7.0 mmol/l), whether treated or not - Neuromuscular toxicity 6) Bitherapy with Cyclosporin and MMF or Tacrolimus and MMF - Cyclosporin concentration C0 = 100 ng/ml or C2 = 500 ng/ml, OR - Tacrolimus concentration = 6 ng/ml 7) Liver biopsy performed in the 6 months preceding inclusion for patients with a post-transplant period of 5 years 8) Negative pregnancy test for women of childbearing potential and reliable contraception for women of childbearing potential. Contraception must be used before start of treatment with CellCept, duringf treatment, and 6 weeks after the last dose of CellCept Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient participating in another trial 2) Acute rejection in the 6 months preceding screening 3) History of corticoresistant rejection 4) Chronic rejection 5) Significant ductopenia (absence of interlobular biliary ducts in more than 30 % of the portal spaces) in the pre-screening graft biopsy. 6) Pre-transplant diabetes (fasting glycaemia > 7.0 mmol/l), whether treated or not, except for cases of diabetes which resolved after transplantation 7) LT for auto-immune hepatitis or primary sclerosing cholangitis 8) Transplantation due to C virus cirrhosis with reinfection lesions of the transplanted organ which may require treatment with interferon-ribavirine in the year following inclusion 9) Contraindications to MMF (Hb < 10g/dl, Neutrophils < 1000/mm3) 10) Immunosuppression with Rapamycin or Azathioprin 11) A woman who is, or might become, pregnant or is lactating 12) Creatinine clearance < 25ml/mn 13) Double liver / kidney trasplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that in liver transplant patients with side effects of calcineurin inhibitors, withdrawal of these products, followed by MMF monotherapy with therapeutic drug monitoring of MPA, is a reliable approach which does not lead to a significant increase of the risk rejection and which has a positive impact on the side effects of calcineurin inhibitors.;Secondary Objective: To demonstrate that this strategy has a positive impact on the side effects of calcineurin inhibitors without modifying the risk of infection or malignancy. To propose an innovative approach of immunosuppression which allows to control the side effects of calcineurin inhibitors without increasing the costs of maintenance immunosuppression;Primary end point(s): Not applicable. | — |
Countries
Belgium
Outcome results
None listed