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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00151632
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Rennes University Hospital
• Public title: Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil After Liver Transplantation MMF-FK
• Scientific title: Evaluation of the Benefit/Risk Ratio of a Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil on the Prevention of Complications in Adult Liver Transplantation
• Date of first enrolment: May 2003
• Target sample size: 195
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00151632
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Karim Boudjema, MD, PhD
• Affiliation: CHU Rennes

• Name: Eric Bellissant, MD, PhD
• Affiliation: CHU Rennes

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Evidence of Liver Transplantation

Intervention(s)

Drug: Mycophenolate mofetil

Drug: Tacrolimus

Primary Outcome(s)

Onset of acute rejection (criterion evaluating the risk) [Time Frame: between Day 1 and Week 48]

Onset of at least one complication (hypertension, renal failure, diabetes) requiring a specific treatment (criterion evaluating the benefit) [Time Frame: between Week 9 and Week 48]

Secondary Outcome(s)

Onset of hypertension, renal failure, diabetes, hypercholesterolemia, or of a serious adverse effect of mycophenolate mofetil [Time Frame: between Day 1 and Week 48]

Secondary ID(s)

AFSSAPS 030200

PHRC/01-01

CIC0203/011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, France