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

NCT02897895 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2016-09-13

No results posted yet for this study

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

BIOLOGICAL

levels of CNI in whole blood

BIOLOGICAL

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

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Urielle Desalbres · Assistance Publique Hôpitaux de Marseille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897895 on ClinicalTrials.gov