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

NCT02897895 | Unknown

• 1 other identifier: 2014-16
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

Lung transplantation in end-stage lung diseases

Outcome Measures

Primary Outcomes (1)

• number of episodes of acute rejection after LTx

  6 months

Study Arms (2)

new strategy of immunosuppression monitoring

EXPERIMENTAL

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

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

strategy of reference

ACTIVE COMPARATOR

CNI (inhibitor of Calcineurin) blood levels alone

Biological: levels of CNI in whole blood

Interventions

levels of CNI in whole blood BIOLOGICAL

new strategy of immunosuppression monitoring; strategy of reference

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

new strategy of immunosuppression monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, Marseille, 13354, France

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Calcineurin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phosphoprotein Phosphatases; Phosphoric Monoester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Urielle Desalbres

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Martine Reynaud Gaubert, Professor

CONTACT

martine.reynaud@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

FR (1)