Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in 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

UNKNOWN

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-12-31

Brief Summary

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The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.

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Detailed Description

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Conditions

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Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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new strategy of immunosuppression monitoring

evaluation of calcineurin activity (CN-a) in combination with CNI blood levels

Group Type EXPERIMENTAL

levels of CNI in whole blood

Intervention Type BIOLOGICAL

Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)

Intervention Type BIOLOGICAL

strategy of reference

CNI (inhibitor of Calcineurin) blood levels alone

Group Type ACTIVE_COMPARATOR

levels of CNI in whole blood

Intervention Type BIOLOGICAL

Interventions

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levels of CNI in whole blood

Intervention Type BIOLOGICAL

Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient placed on the national waiting list for lung transplantation
* First de novo lung transplantation (single or double LTx)
* Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)