Status:
TERMINATED
Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil After Liver Transplantation
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Evidence of Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 immunoprophylax...
Detailed 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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00151632
Start Date
May 1 2003
End Date
May 1 2009
Last Update
July 4 2012
Active Locations (8)
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1
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre
Caen, France, 14033
2
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, France, 92110
3
Service d'Hépatogastroentérologie - Hôpital Henri Mondor
Créteil, France, 94010
4
Chirurgie Générale et Digestive - Hôpital de La Croix Rousse
Lyon, France, 69317