Evidence of Liver Transplantation Clinical Trial
— MMF-FKOfficial 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
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.
Status | Terminated |
Enrollment | 195 |
Est. completion date | May 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Service de Chirurgie Digestive - Hôpital de la Côte de Nacre | Caen | |
France | Service d'Hépatogastroentérologie - Hôpital Beaujon | Clichy | |
France | Service d'Hépatogastroentérologie - Hôpital Henri Mondor | Créteil | |
France | Chirurgie Générale et Digestive - Hôpital de La Croix Rousse | Lyon | |
France | Service d'Hépaogastroentérologie - Hôpital Saint Eloi | Montpellier | |
France | Service de Chirurgie Générale - Hôpital Cochin | Paris | |
France | Département de Chirurgie Viscérale - Hôpital Pontchaillou | Rennes | |
France | Centre Hépato-biliaire - Hôpital Paul Brousse | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Ministry of Health, France |
France,
Jain AB, Hamad I, Rakela J, Dodson F, Kramer D, Demetris J, McMichael J, Starzl TE, Fung JJ. A prospective randomized trial of tacrolimus and prednisone versus tacrolimus, prednisone, and mycophenolate mofetil in primary adult liver transplant recipients: an interim report. Transplantation. 1998 Nov 27;66(10):1395-8. — View Citation
Klupp J, Glanemann M, Bechstein WO, Platz KP, Langrehr JM, Keck H, Settmacher U, Radtke C, Neuhaus R, Neuhaus P. Mycophenolate mofetil in combination with tacrolimus versus Neoral after liver transplantation. Transplant Proc. 1999 Feb-Mar;31(1-2):1113-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Onset of acute rejection (criterion evaluating the risk) | between Day 1 and Week 48 | No | |
Primary | Onset of at least one complication (hypertension, renal failure, diabetes) requiring a specific treatment (criterion evaluating the benefit) | between Week 9 and Week 48 | Yes | |
Secondary | Onset of hypertension, renal failure, diabetes, hypercholesterolemia, or of a serious adverse effect of mycophenolate mofetil | between Day 1 and Week 48 | Yes |
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