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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Lung Diseases

Treatments: Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs); Biological: levels of CNI in whole blood

Study type: Interventional

Funder types: Other

Identifiers

NCT02897895

2014-16

Details and patient eligibility

About

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

new strategy of immunosuppression monitoring

Experimental group

Description:

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

Treatment:

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

Biological: levels of CNI in whole blood

strategy of reference

Active Comparator group

Description:

CNI (inhibitor of Calcineurin) blood levels alone

Treatment:

Biological: levels of CNI in whole blood