Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil After Liver Transplantation

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The prevention of graft rejection after liver transplantation benefits nowadays from a variety of newly developed immunosuppressive agents. This allows more flexible and individualized immunoprophylaxis and gives an opportunity to reduce the long-term side effects (hypertension, renal failure, diabetes, etc.) of immunosuppression. The purpose of this study is to evaluate, in liver transplanted patients, if low doses of tacrolimus, given in combination with mycophenolate mofetil, can result in a lower rate of long-term side effects without increasing the rate of graft rejection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Collaborator: Ministry of Health, France
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Adults over 18 years of age

• Primary liver transplantation

• Immunosuppressive treatment associating tacrolimus and steroids at low doses (< 20 mg/d)

• Written informed consent

Non-Inclusion Criteria:

• Pregnancy or ineffective contraception

• Immunosuppressive treatment

• Blood group incompatibility with the donor

• Autoimmune hepatitis

• Fulminant hepatitis

• Primary sclerosing cholangitis

• Combined transplantations

• Reduced liver

• Living donor

• Treated hypertension and/or diastolic pressure ≥ 90 mmHg and/or systolic pressure ≥ 140 mmHg,

• Acute or chronic renal failure(creatininemia ≥ 130 μmol/L) before transplantation

• Treated diabetes and/or fasting glycemia ≥ 7 mmol/L

• Treated hypercholesterolemia and/or cholesterolemia ≥ 7 mmol/L

• post-operative creatininemia ≥ 200 μmol/L