Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation (BASALT)

University of Limoges (UL)

Status and phase

Terminated

Phase 4

Conditions

Lung and Heart-lung Transplantation

Treatments

Drug: Tacrolimus and MMF

Study type

Interventional

Funder types

Other

Identifiers

NCT00975663

I07038

Details and patient eligibility

About

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.

Full description

This research will be based on a prospective randomized trial comparing optimized TDM of tacrolimus and MMF to the current strategy of tacrolimus and MMF dose adjustment in lung transplant recipients. The study will focus on the first three years post-transplantation, as treatment failures (including BOS) occur mainly during this post-transplantation period. As the aim of tacrolimus and MMF dose individualization is to avoid over- or underexposure, for the purpose of this study treatment failure will be a composite criterion gathering events which reflect both over- and underexposure to tacrolimus and MMF.

Optimized TDM of tacrolimus and MMF based on blood tacrolimus and plasma MPA AUC Bayesian estimation will be compared to current strategies: tacrolimus dose adjustment based on trough levels (C0) and administration of a standard dose of MMF, decreased by the pulmonologist in case of adverse drug reactions or increased in case of inefficacy. The efficacy of optimized strategy vs. current strategies will be mainly evaluated through the incidence of treatment failure.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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