Lung Diseases
Conditions
Keywords
Lung transplantation in end-stage lung diseases
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.
Interventions
BIOLOGICALlevels of CNI in whole blood
BIOLOGICALCalcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of episodes of acute rejection after LTx | 6 months |
Countries
France
Contacts
Primary ContactMartine Reynaud Gaubert, Professor
Outcome results
None listed