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

Not Applicable

• Conditions: Lung Diseases
• Interventions: Biological: levels of CNI in whole blood; Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)

• Registration Number: NCT02897895
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Last Update Submitted: 2016-09-12
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13
• Study Start: 2016-12
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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)

Exclusion Criteria

• Previous lung transplantation or other solid organ transplantation
• Combined lung transplantation with either liver or renal transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
new strategy of immunosuppression monitoring	levels of CNI in whole blood	evaluation of calcineurin activity (CN-a) in combination with CNI blood levels
new strategy of immunosuppression monitoring	Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)	evaluation of calcineurin activity (CN-a) in combination with CNI blood levels
strategy of reference	levels of CNI in whole blood	CNI (inhibitor of Calcineurin) blood levels alone

Primary Outcome Measures

Name	Time	Method
number of episodes of acute rejection after LTx	6 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France