Clinical Study Evaluating Two Treatment Protocols for Immunosuppresive Drugs. Looking at 3-year Incidence of CLAD.

2016-10-19 02:38:21 | BioPortfolio


A controlled randomized, open-label, multi-centre study evaluating if an immunosuppressive protocol, based on ATG-induction, once daily tacrolimus-dose (Advagraf®), mycophenolate mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD) after lung transplantation, in comparison with a standard cyclosporin-based protocol.


Study purpose:

To evaluate whether the use of a once-daily tacrolimus-dose regimen (Advagraf®), based on anti-thymocyte globuline (Thymoglobulin®) induction, mycophenolate mofetil (MMF) and corticosteroids, reduces the cumulative incidence of CLAD after de novo lung transplantation at 36 months, in comparison with a twice-daily cyclosporin-based protocol, otherwise identical between groups.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Lung Transplantation


Cyclosporine, Mycophenolate mofetil (MMF), Rabbit Anti thymocyte globuline, Corticosteroids, Tacrolimus


Not yet recruiting


Vastra Gotaland Region

Results (where available)

View Results


Published on BioPortfolio: 2016-10-19T02:38:21-0400

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Medical and Biotech [MESH] Definitions

A group of corticosteroids carrying hydroxy groups, usually in the 11- or 17-positions. They comprise the bulk of the corticosteroids used systemically. As they are relatively insoluble in water, salts of various esterified forms are often used for injections or solutions.

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A 17-KDa cytoplasmic PEPTIDYLPROLYL ISOMERASE involved in immunoregulation. It is a member of the cyclophilin family of proteins that binds to CYCLOSPORINE.

Hemagglutination test in which Coombs' reagent (antiglobulin, or anti-human globulin rabbit immune serum) is added to detect incomplete (non-agglutinating, univalent, blocking) antibodies coating erythrocytes. The direct test is applied to red cells which have been coated with antibody in vivo (e.g., in hemolytic disease of newborn, autoimmune hemolytic anemia, and transfusion reactions). The indirect test is applied to serum to detect the presence of antibody (e.g., in detection of incompatibility in cross-matching tests, detection and identification of irregular antibodies, and in detection of antibodies not identifiable by other means).

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