NCT02897895

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Diseases

Interventions

Type	Name	Description
BIOLOGICAL	levels of CNI in whole blood
BIOLOGICAL	Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2016-09-13
• Last updated: 2016-09-13

Locations

1 site across 1 country: France