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(NCT02897895)

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.
  • Biological: levels of CNI in whole blood
    • Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts 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

      1 locations

      France (1)
      • Assistance Publique Hopitaux de Marseille
        not yet recruiting
        Marseille, France, 13354
      Status:
      not yet recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      30 November, 2016
      Updated:
      11 September, 2016
      Participants:
      134
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