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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)

Primary Purpose

Lung Diseases

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

levels of CNI in whole blood

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

About this trial

This is an interventional prevention trial for Lung Diseases focused on measuring Lung transplantation in end-stage lung diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

new strategy of immunosuppression monitoring

strategy of reference

Arm Description

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

CNI (inhibitor of Calcineurin) blood levels alone

Outcomes

Primary Outcome Measures

number of episodes of acute rejection after LTx

Secondary Outcome Measures

Full Information

NCT ID

NCT02897895

First Posted

September 8, 2016

Last Updated

September 12, 2016

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT02897895

Brief Title

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

Acronym

CalciMo-TP

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases

Keywords

Lung transplantation in end-stage lung diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

new strategy of immunosuppression monitoring

Arm Type

Experimental

Arm Description

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

Arm Title

strategy of reference

Arm Type

Active Comparator

Arm Description

CNI (inhibitor of Calcineurin) blood levels alone

Intervention Type

Biological

Intervention Name(s)

levels of CNI in whole blood

Intervention Type

Biological

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

number of episodes of acute rejection after LTx

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martine Reynaud Gaubert, Professor

martine.reynaud@ap-hm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Urielle Desalbres

Organizational Affiliation

Assistance Publique Hôpitaux de Marseille

Official's Role

Study Director

Facility Information:

Facility Name

Assistance Publique Hopitaux de Marseille

City

Marseille

ZIP/Postal Code

13354

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

reynaud gaubert martine

martine.reynaud@ap-hm.fr

First Name & Middle Initial & Last Name & Degree

reynaud gaubert martine

12. IPD Sharing Statement

Learn more about this trial

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

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