Not Signed In -
Tacrolimus |
FK 506; Prograf |
Clinical Trial: Reduction of Tacrolimus Dose in Association with Mycophenolate Mofetil After Liver Transplantation.
This study is currently recruiting patients.
Verified by Rennes University Hospital September 2005
|
Purpose
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...) 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.
| Condition | Intervention | Phase |
|---|---|---|
| Liver Transplantation | Drug: Tacrolimus / Mycophenolate mofetil | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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
Further Study Details:
Primary Outcomes: Onset of acute rejection between Day 1 and Week 48 (criterion evaluating the risk); Onset of at least one complication (hypertension, renal failure, diabetes) requiring a specific treatment between Week 9 and Week 48 (criterion evaluating the benefit).
Secondary Outcomes: Onset of hypertension, renal failure, diabetes, hypercholesterolemia, or of a serious adverse effect of mycophenolate mofetil.
Expected Total Enrollment: 240
Secondary Outcomes: Onset of hypertension, renal failure, diabetes, hypercholesterolemia, or of a serious adverse effect of mycophenolate mofetil.
Expected Total Enrollment: 240
Study start: May 2003
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...) will allow to evaluate the efficacy of both treatment schedules.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Adult over 18 years
- Primary liver transplantation
- Immunosuppressive treatment associating tacrolimus and steroids at low doses (<20 mg/d)
- Informed written consent
Exclusion Criteria:
- Pregnancy
- Immunosuppressive treatment
- Blood group incompatibility with the donor
- Autoimmune hepatitis
- Primary sclerosing cholangitis
- Combined transplantations
- Hypertension
- Acute or chronic renal failure
- Diabetes
- Hypercholesterolemia
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00151632
Karim Boudjema, MD, PhD 33-2-9928-4265 karim.boudjema@chu-rennes.fr
Eric Bellissant, MD, PhD 33-2-9928-9200 eric.bellissant@chu-rennes.fr
Eric Bellissant, MD, PhD 33-2-9928-9200 eric.bellissant@chu-rennes.fr
France
Département de Chirurgie Viscérale - Hôpital Pontchaillou, Rennes, 35033, France; Recruiting
Karim Boudjema, MD, PhD 33-2-9928-4265 karim.boudjema@chu-rennes.fr
Eric Bellissant, MD, PhD 33-2-9928-3715 eric.bellissant@chu-rennes.fr
Karim Boudjema, MD, PhD, Principal Investigator
Christophe Camus, MD, Sub-Investigator
Richard Lorho, MD, Sub-Investigator
Michel Messner, MD, Sub-Investigator
Eric Bellissant, MD, PhD 33-2-9928-3715 eric.bellissant@chu-rennes.fr
Karim Boudjema, MD, PhD, Principal Investigator
Christophe Camus, MD, Sub-Investigator
Richard Lorho, MD, Sub-Investigator
Michel Messner, MD, Sub-Investigator
Service de Chirurgie Générale - Hôpital Cochin, Paris, 75679, France; Recruiting
Yvon Calmus, MD 33-1-5841-1723 yvon.calmus@cch.aphp.fr
Yvon Calmus, MD, Principal Investigator
Filomena Conti, MD, Sub-Investigator
Yvon Calmus, MD, Principal Investigator
Filomena Conti, MD, Sub-Investigator
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre, Caen, 14033, France; Recruiting
Ephrem Salame, MD 33-2-3106-4467 salame-e@chu-caen.fr
Ephrem Salame, MD, Principal Investigator
Ephrem Salame, MD, Principal Investigator
Service d''''Hépatogastroentérologie - Hôpital Beaujon, Clichy, 92110, France; Recruiting
François Durand, MD 33-1-4087-5530 francois.durand@bjn.aphp.fr
François Durand, MD, Principal Investigator
Claire Francoz, MD, Sub-Investigator
François Durand, MD, Principal Investigator
Claire Francoz, MD, Sub-Investigator
Service d''''Hépatogastroentérologie - Hôpital Henri Mondor, Créteil, 94010, France; Recruiting
Christophe Duvoux, MD 33-1-4981-2357 christophe.duvoux@hmn.aphp.fr
Christophe Duvoux, MD, Principal Investigator
Camille Barrault, MD, Sub-Investigator
Charlotte Costentin, MD, Sub-Investigator
Christophe Duvoux, MD, Principal Investigator
Camille Barrault, MD, Sub-Investigator
Charlotte Costentin, MD, Sub-Investigator
Service d''''Hépaogastroentérologie - Hôpital Saint Eloi, Montpellier, France; Recruiting
Georges-Philippe Pageaux, MD 33-4-6733-7390 gp-pageaud@chu-montpellier.fr
Georges Pageaux, MD, Principal Investigator
Michaël Bismuth, MD, Sub-Investigator
Georges Pageaux, MD, Principal Investigator
Michaël Bismuth, MD, Sub-Investigator
Centre Hépato-biliaire - Hôpital Paul Brousse, Villejuif, France; Recruiting
Didier Samuel, MD 33-1-4559-3028 didier.samuel@pbr.aphp.fr
Didier Samuel, MD, Principal Investigator
Faouzi Saliba, MD, Sub-Investigator
Didier Samuel, MD, Principal Investigator
Faouzi Saliba, MD, Sub-Investigator
Chirurgie Générale et Digestive - Hôpital de La Croix Rousse, Lyon, 69317, France; Recruiting
Christian Ducerf, MD 33-4-7207-1626 christian.ducerf@chu-lyon.fr
Christian Ducerf, MD, Principal Investigator
Christian Ducerf, MD, Principal Investigator
Study chairs or principal investigators
Karim Boudjema, MD, PhD, Study Director, CHU Rennes
Eric Bellissant, MD, PhD, Study Chair, CHU Rennes
More Information
Publications
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.
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. No abstract available.
Study ID Numbers: AFSSAPS 030200; PHRC/01-01; CIC0203/011
Last Updated: September 8, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00151632
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 8, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00151632
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13
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