(76) A Scandinavian Controlled Randomized Open-Label and Multi-Center Study Evaluating if Once-Daily Tacrolimus versus Twice-Daily Cyclosporine De Novo, Reduces the 3-Year Incidence of Chronic Lung Allograft Dysfunction after Lung Transplantation

• Published in: The Journal of heart and lung transplantation Vol. 42; no. 4; p. S44
• Main Authors: Dellgren, G., Lund, T., Raivio, P., Leuckfeld, I., Svahn, J., Olsen, P., Halme, R., Fiane, A., Lindstedt, S., Riise, G., Magnusson, J.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.04.2023
• ISSN: 1053-2498; 1557-3117
• DOI: 10.1016/j.healun.2023.02.092

Level of evidence is low regarding the choice of calcineurin inhibitor (CNI) for immunosuppression after lung transplantation (LTx). A randomized clinical trial (RCT) was therefore designed and compared tacrolimus with cyclosporine after LTx. The ScanCLAD study is an investigator-initiated, open-label, multi-center RCT evaluating if an immunosuppressive protocol based on ATG-induction, once daily tacrolimus-dose, mycophenolate mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD) after LTx, compared to a cyclosporine-based protocol with all other immunosuppressive and prophylactic drugs being identical between groups. Patients were recruited from all institutions performing LTx within the Scandia transplant area and were followed for three years, to determine the primary endpoint CLAD, using the most updated definition, as well as more than ten other sub-studies. Recruitment was performed between 2016 and 2019, and 249 patients were correctly randomized, transplanted, received first dose of the study drug and constituted the intention-to-treat population. Groups were well balanced, and all patients were followed with the registration of AE/SAE and lung function tests according to protocol. Last patient was followed for three years in October 2022. The primary outcome will be disclosed as well as survival and some secondary outcomes. The ScanCLAD study investigates which CNI is to be preferred from a CLAD perspective after LTx, and will be revealed at the ISHLT annual meeting in Denver in 2023.