Open AccessEarly conversion to a CNI-free immunosuppression with SRL after renal transplantation—Long-term follow-up of a multicenter trial
Author(s) -
Joachim Andrassy,
Markus Guba,
Antje Habicht,
Michael Fischereder,
Johann Pratschke,
Andreas Pascher,
Katharina Heller,
Bernhard Banas,
Oliver W. Hakenberg,
Thomas Vogel,
Bruno Meiser,
Andrea Dick,
Jens Werner,
Teresa Kauke
Publication year - 2020
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0234396
Subject(s) - medicine , immunosuppression , transplantation , regimen , urology , renal function
Early conversion to a CNI-free immunosuppression with SRL was associated with an improved 1- and 3- yr renal function as compared with a CsA-based regimen in the SMART-Trial. Mixed results were reported on the occurrence of donor specific antibodies under mTOR-Is. Here, we present long-term results of the SMART-Trial. Methods and materials N = 71 from 6 centers (n = 38 SRL and n = 33 CsA) of the original SMART-Trial (ITT n = 140) were enrolled in this observational, non-interventional extension study to collect retrospectively and prospectively follow-up data for the interval since baseline. Primary objective was the development of dnDSA. Blood samples were collected on average 8.7 years after transplantation. Results Development of dnDSA was not different (SRL 5/38, 13.2% vs. CsA 9/33, 27.3%; P = 0.097). GFR remained improved under SRL with 64.37 ml/min/1.73m 2 vs. 53.19 ml/min/1.73m 2 (p = 0.044). Patient survival did not differ between groups at 10 years. There was a trend towards a reduced graft failure rate (11.6% SRL vs. 23.9% CsA, p = 0.064) and less tumors under SRL (2.6% SRL vs. 15.2% CsA, p = 0.09). Conclusions An early conversion to SRL did not result in an increased incidence of dnDSA nor increased long-term risk for the recipient. Transplant function remains improved with benefits for the graft survival.