Antirejection Efficacy in De Novo Renal Transplant Recipients Receiving Everolimus with a Reduced-Exposure Calcineurin Inhibitor-Based Regimen: 24-Month Results from the TRANSFORM Study

H. Tedesco Silva¹, F. Citterio¹, M. Henry¹, T. R. Srinivas¹, Y. Watarai¹, S. Steinberg¹, N. Basic-Jukic¹, V. D. Garcia¹, E. Mor¹, V. R. Peddi¹, P. Narvekar², M. P. Hernandez Gutierrez², P. Bernhardt², J. Pascual¹

¹TRANSFORM Study Group, Basel, Switzerland, ²Novartis Pharma AG, Basel, Switzerland

Meeting: 2019 American Transplant Congress

Abstract number: 105

Keywords: Efficacy, Immunosuppression, Kidney transplantation, Outcome

Session Information

Session Name: Concurrent Session: Kidney Immunosuppression: Novel Regimens and Drug Minimization I

Session Type: Concurrent Session

Date: Sunday, June 2, 2019

Session Time: 4:30pm-6:00pm

Presentation Time: 4:30pm-4:42pm

Location: Veterans Auditorium

*Purpose: To compare the antirejection efficacy outcomes of an everolimus+reduced-exposure CNI (EVR+rCNI) vs mycophenolic acid+standard-exposure CNI (MPA+sCNI) regimen in renal transplant recipients (RTxRs) from the TRANSFORM study (NCT01950819).

*Methods: In this 24-month (M), multicenter, open-label study, de novo RTxRs were randomized to receive EVR+rCNI (N=1022) or MPA+sCNI (N=1015) with induction and steroids. Efficacy assessments included incidence of the composite efficacy failure (treated biopsy-proven acute rejection [tBPAR], graft loss, or death), its components, antibody-mediated rejection, and de novo donor-specific antibodies (dnDSA; any mean fluorescence intensity [MFI]).

*Results: Baseline characteristics were mostly comparable between arms. At M24, the incidence of composite efficacy failure, other efficacy outcomes, and dnDSA was comparable between arms (Table). The overall tBPAR and recurrent tBPAR rates were low in the study and comparable between arms. The incidence of tBPAR was low in both arms in patients who received rabbit anti-thymocyte globulin induction vs those with basiliximab induction. In patients with tBPAR, higher incidences of deceased donors, diabetes, Caucasians, and higher cold ischemia time were reported in the EVR+rCNI arm. Most tBPAR events were mild (grade IA or IB) and occurred in the first 3 months posttransplant in both arms (EVR+rCNI [6.2%] vs MPA+sCNI [5.7%]; Table); severe rejections (grade IIB and III) were more frequent in the EVR+rCNI arm. At tBPAR onset, the mean EVR trough level (C0) was 5.1 ng/mL and mean TAC C0 were 5.4 (EVR+rTAC) and 9.5 (MPA+sTAC) ng/mL. Similar TAC and cyclosporine A C0 were reported between patients with and without tBPAR in the EVR+rCNI arm from Week 4 onwards.

*Conclusions: De novo EVR+rCNI regimen provides comparable antirejection efficacy to MPA+sCNI with most tBPAR events of mild severity, onset within the first 3 months, and comparable drug exposure patterns in patients with vs without tBPAR.

To cite this abstract in AMA style:

Silva HTedesco, Citterio F, Henry M, Srinivas TR, Watarai Y, Steinberg S, Basic-Jukic N, Garcia VD, Mor E, Peddi VR, Narvekar P, Gutierrez MPHernandez, Bernhardt P, Pascual J. Antirejection Efficacy in De Novo Renal Transplant Recipients Receiving Everolimus with a Reduced-Exposure Calcineurin Inhibitor-Based Regimen: 24-Month Results from the TRANSFORM Study [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/antirejection-efficacy-in-de-novo-renal-transplant-recipients-receiving-everolimus-with-a-reduced-exposure-calcineurin-inhibitor-based-regimen-24-month-results-from-the-transform-study/. Accessed May 17, 2025.

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