Lung and Heart-lung Transplantation Clinical Trial
Official title:
Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment