Prospective Donor-Specific CellUlar Alloresponse Assessment for Immunosuppression MinImization in De Novo Renal Transplantation: Results of a Randomized Controlled Biomarker-Guided Trial
1Kidney transplantation Unit, Bellvitge University Hospital- IDIBELL, L'Hospitalet de Llobregat. Barcelona, Spain, 2Kidney transplantation Unit, Charité - Universitätsmedizin Berlin, Berlin, Germany, 3Kidney transplantation Unit, Amsterdam Medical Centre, Amsterdam, Netherlands, 4Nephrology department, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic, 5Department of Hepatobiliary Surgery and Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 6Nephrology, Kidney transplantation Unit, Université de Nantes, Nantes, France, 7Nephrology, Hospital Marques de Valdecilla, Santander, Spain, 8Kidney transplantation Unit, University Hospital Regensburg, Regensburg, Germany, 9Institute for Medical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany
Meeting: 2020 American Transplant Congress
Abstract number: 224
Keywords: Calcineurin, Kidney transplantation, Rejection, T cell reactivity
Session Information
Session Name: Novel Tools to Assess Immunosuppressive Efficacy
Session Type: Oral Abstract Session
Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:45pm
Presentation Time: 3:27pm-3:39pm
Location: Virtual
*Purpose: Early immunosuppression minimization is associated with higher rates of BPAR. Preformed donor-specific T-cell alloreactivity (DST) assessed with an IFN-γ ELISPOT assay has shown to identify patients at low BPAR risk. The Cellimin Study is a biomarker-driven randomized trial investigating the feasibility of maintenance IS minimization with tacrolimus monotherapy (TACmo) based on preformed DST.
*Methods: 12-mo randomized, biomarker-guided trial with first low immunological risk KT, from 8 European transplant centers. DST- patients were randomized 1:1 to either TACmo with rapid MMF and steroid withdrawal or Standard of Care (StdCare) with TAC/MMF/prednisone. DST+ received similar IS as DST-/StdCare, all with Basiliximab. The primary objective was to show the utility of baseline DST, assuming 6-mo 10% BPAR (Banff≥IA) in DST-/StdCare with a non-inferiority limit of 15% in DST-/TACmo group. 672 patients had to be screened and 272 randomized.
*Results: From 12/2015 to 11/2018, 186 consecutive KT were screened. Due to too low recruitment rates, the trial was stopped and analysed for mechanistic purposes. 17 patients were drop-out and 168 evaluated. 67(36%) were DST+, whereas 101(64%) DST- and randomized: 53 StdCare and 48 TACmo. 37/48(77%) DST-/TACmo were on protocol at 12mo. There were no differences regarding graft and patient survival between groups. 6-mo BPAR was similar among DST- (6[12.5%] vs 3[7.5%], p=0.19) but higher in DST+ (12[18%], LogRank=0.04). While all BPAR were TCMR in DST-, 50% were ABMR in DST+. DST- showed numerically lower 12-mo dnDSA than DST+ (6[13%], 5[11%], 10[21%]). Lower CMV disease and PVAN rates were observed in DST-/TACmo (2%, 6%, 6%,p=0.59 for CMV and 0%, 7.5%, 1,5%,p=0.05 for PVAN in DST-/TACmo, DST-/StdCare and DST+, respectively).
*Conclusions: Pre-transplant DST assessment may be a useful tool to safely allocate patients on TAC monotherapy. Notably, pre-transplant DST+ patients may need a closer follow-up as they seem to be at higher risk of more severe BPAR.
To cite this abstract in AMA style:
Bestard O, Reinke P, Bemelman F, Viklicky O, Koch M, Giral M, Ruiz J, Banas B, Crespo E, Meneghini M, Volk H, Grinyo J. Prospective Donor-Specific CellUlar Alloresponse Assessment for Immunosuppression MinImization in De Novo Renal Transplantation: Results of a Randomized Controlled Biomarker-Guided Trial [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/prospective-donor-specific-cellular-alloresponse-assessment-for-immunosuppression-minimization-in-de-novo-renal-transplantation-results-of-a-randomized-controlled-biomarker-guided-trial/. Accessed May 16, 2025.« Back to 2020 American Transplant Congress