Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung and Heart-lung Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Optimized TDM of tacrolimus and MMF dosing

Group Type EXPERIMENTAL

Tacrolimus and MMF

Intervention Type DRUG

Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.

2

Current tacrolimus and MMF dosing strategies

Group Type ACTIVE_COMPARATOR

Tacrolimus and MMF

Intervention Type DRUG

Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.

Interventions

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Tacrolimus and MMF

Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.

Intervention Type DRUG

Tacrolimus and MMF

Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No