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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 (CalciMo-TP)

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ClinicalTrials.gov Identifier: NCT02897895
Recruitment Status : Not yet recruiting
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Diseases Biological: levels of CNI in whole blood Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: new strategy of immunosuppression monitoring
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)
Active Comparator: strategy of reference
CNI (inhibitor of Calcineurin) blood levels alone
Biological: levels of CNI in whole blood



Primary Outcome Measures :
  1. number of episodes of acute rejection after LTx [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897895


Contacts
Contact: Martine Reynaud Gaubert, Professor martine.reynaud@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: reynaud gaubert martine       martine.reynaud@ap-hm.fr   
Principal Investigator: reynaud gaubert martine         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle Desalbres Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02897895     History of Changes
Other Study ID Numbers: 2014-16
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Assistance Publique Hopitaux De Marseille:
Lung transplantation in end-stage lung diseases

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action