Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Treatments: Immunosuppressive Agents; Tacrolimus

Criteria

Inclusion Criteria

• Male and female patients aged 18 years or more

• CF and non-CF patients receiving single-lung or double-lung or heart-lung transplantation for the first time

• Patients on oral tacrolimus and MMF for at least 48 hours at the time of inclusion (administration via a naso-gastric tube possible if necessary)

• Patients without progressive chronic pathology jeopardizing short term patient and graft survival

• Patients accepting to comply with at least the evaluation visits planned in the investigation center over the first three years post-transplantation (D7, D14, M1, M3, M6, M12, M18, M24, M30, M36)

• Patients giving their free and informed written consent to participate in this study

• Patients with a health insurance policy or registered under a health insurance program

Exclusion Criteria:

• Patients aged less than 18 years or patients over 18 years under guardianship

• Patients who disagree with this research

• Patients with a contra-indication to receiving tacrolimus or MMF

• Patients on cyclosporine, sirolimus or everolimus

• Patients who have already benefited from a solid organ transplantation in the past (including lung or heart-lung transplantation)

• Patients infected by Burkholderia cenocepacia (Burkholderia cepacia genomovar III)

• Patients receiving HIV protease inhibitors (major pharmacokinetic interaction with tacrolimus)

• Pregnant or breastfeeding women or those of child-bearing age who do not use an efficient contraceptive method

• Drug users or patients suffering from neuro-psychiatric disorders preventing them from both proper comprehension of the protocol and reliable consent

• Patients already participating in another interventional clinical trial