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NCT02897895 Clinical Trial

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

Lung Diseases Clinical Trial

— CalciMo-TP  

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02897895
Other study ID # 2014-16
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 8, 2016
Last updated September 12, 2016
Start date December 2016
Est. completion date December 2022

Study information
Verified date September 2016
Source Assistance Publique Hopitaux De Marseille
Contact Martine Reynaud Gaubert, Professor
Email martine.reynaud@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 134
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• levels of CNI in whole blood

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

Locations
Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of episodes of acute rejection after LTx 6 months Yes
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