Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil After Liver Transplantation (MMF-FK)

R

Rennes University Hospital

Status and phase

Terminated
Phase 3

Conditions

Evidence of Liver Transplantation

Treatments

Drug: Tacrolimus
Drug: Mycophenolate mofetil

Study type

Interventional

Funder types

Other

Identifiers

NCT00151632
CIC0203/011
PHRC/01-01 (Other Identifier)
AFSSAPS 030200

Details and patient eligibility

About

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.

Full description

Tacrolimus and mycophenolate mofetil are currently approved immunosuppressive agents for the prevention of acute and chronic rejection in liver transplantation. Adverse effects of tacrolimus are dose-dependent and appear early after the onset of treatment. To prevent side effects, we propose to combine reduced doses of tacrolimus with another immunosuppressant, i.e. mycophenolate mofetil, administered at usual doses. This study evaluates the interest of this combination and, subsequently, the pharmacokinetics of mycophenolate mofetil in this therapeutic context. Patients undergoing liver transplantation will be randomized to tacrolimus at normal doses or to the combination of tacrolimus at half doses and mycophenolate mofetil. A corticotherapy will be associated in both groups. The safety will be evaluated on the number of graft rejections between day 1 after transplantation and week 48; the onset of complications (hypertension, renal failure, diabetes, etc.) will allow to evaluate the efficacy of both treatment schedules.

Enrollment

195 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

195 participants in 2 patient groups

MMF+FK
Experimental group
Description:
Low doses of tacrolimus in association with mycophenolate mofetil
Treatment:
Drug: Mycophenolate mofetil
Drug: Tacrolimus
FK
Active Comparator group
Description:
Full recommended doses of tacrolimus
Treatment:
Drug: Tacrolimus

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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