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Early Conversion to a CNI-Free Immunosuppression with SRL after Renal Tx – 10 yr Follow-Up Analysis of a Prospective Multicenter Trial

J. Andrassy,1 M. Guba,1 A. Habicht,2 M. Fischereder,3 A. Pascher,4 K. Heller,5 B. Banas,6 O. Hakenberg,7 T. Vogel,8 T. Kauke.1

1Surgery, Ludwig-Maximilans-University, Munich, Germany
2Transplant, Ludwig-Maximilans-University, Munich, Germany
3Nephrology, MED IV, Ludwig-Maximilans-University, Munich, Germany
4Surgery, Charitée University, Berlin, Germany
5Medicine, University of Erlangen, Erlangen, Germany
6Internal Medicine II, University of Regensburg, Regensburg, Germany
7Urology, University of Rostock, Rostock, Germany
8Surgery, University of Munster, Munster, Germany.

Meeting: 2018 American Transplant Congress

Abstract number: C64

Keywords: Antibodies, Kidney transplantation, Sirolimus (SLR)

Session Information

Session Name: Poster Session C: Kidney Immunosuppression: Novel Regimens and Drug Minimization

Session Type: Poster Session

Date: Monday, June 4, 2018

Session Time: 6:00pm-7:00pm

 Presentation Time: 6:00pm-7:00pm

Location: Hall 4EF

Introduction: A prospective multicenter trial comparing an early conversion to a CNI-free immunosuppression with SRL, MMF and steroids with a conventional CsA treatment following renal Tx (SMART-Trial) showed an improved 1- and 3- yr renal function for SRL. This trial was started > 10yrs ago. The aim now was to use this study's controlled cohort to investigate the longterm effects of a SRL-based immunosuppression and the impact on donor specific antibodies.

Methods: Patients were recruited from the “SMART” trial (n=140) to primarily investigate the development of dnDSA. Secondary outcome parameters were graft and patient survival, -function, acute rejections and malignancy. Only n=13 were “lost to follow-up”. 53%, n=74 patients from 6 centers (n=39 SRL and n=35 CsA) could be included for the dnDSA analysis. Blood samples for dnDSA analysis were collected with a mean of 8.7 years after Tx.

Results: There were less dnDSA positive patients in the SRL arm (6/39, 15.4%) compared to CsA (10/35, 28.6%), (P=0.089). GFR (Nankivell) remained significantly better under SRL with 64.37 ml/min/1.73m2 vs. 53.19 ml/min/1.73m2 (p = 0.044). Considering the original “SMART” population (N=140), patient survival did not differ between groups at 5 years or later on. There was a significant difference in graft failure (11.3% SRL vs. 24.6% CsA, p=0.045), resulting from an accumulated graft failure rate occurring after 8 years in the CsA group. Significantly more tumors occurred in the CsA arm (15/69=22.1%) compared to SRL(4/71 = 5.8%, p = 0.012). Therapy discontinuations were significantly more often under SRL (p<.01).

Conclusions: In this long-term follow up analysis, an early conversion to SRL did not result in an increased incidence of dnDSA. Longterm graft survival was significantly better under SRL and positive effects were seen for graft function and malignancy. However, therapy discontinuations under SRL remain a problem.

CITATION INFORMATION: Andrassy J., Guba M., Habicht A., Fischereder M., Pascher A., Heller K., Banas B., Hakenberg O., Vogel T., Kauke T. Early Conversion to a CNI-Free Immunosuppression with SRL after Renal Tx – 10 yr Follow-Up Analysis of a Prospective Multicenter Trial Am J Transplant. 2017;17 (suppl 3).

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To cite this abstract in AMA style:

Andrassy J, Guba M, Habicht A, Fischereder M, Pascher A, Heller K, Banas B, Hakenberg O, Vogel T, Kauke T. Early Conversion to a CNI-Free Immunosuppression with SRL after Renal Tx – 10 yr Follow-Up Analysis of a Prospective Multicenter Trial [abstract]. https://atcmeetingabstracts.com/abstract/early-conversion-to-a-cni-free-immunosuppression-with-srl-after-renal-tx-10-yr-follow-up-analysis-of-a-prospective-multicenter-trial/. Accessed May 13, 2025.

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