Early conversion to a CNI-free immunosuppression with SRL after renal transplantation—Long-term follow-up of a multicenter trial

Joachim Andrassy, Markus Guba, Antje Habicht, Michael Fischereder, Johann Pratschke, Andreas Pascher, Katharina M Heller, Bernhard Banas, Oliver Hakenberg, Thomas Vogel, Bruno Meiser, Andrea Dick, Jens Werner, Teresa Kauke and for the SMART-Study Group

PLOS ONE, 2020, vol. 15, issue 8, 1-18

Abstract: Introduction: 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/1.73m2 vs. 53.19 ml/min/1.73m2 (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.

Date: 2020
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0234396

DOI: 10.1371/journal.pone.0234396

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