Renal Function at Five Years from a Randomized Multicenter Trial of Belatacept-Based CNI Free and Early Steroid Withdrawal Immunosuppression

E. Yanqui¹, H. Hames¹, A. R. Shields¹, T. Shi¹, A. L. Christianson¹, J. Kremer², A. Govil¹, R. R. Alloway¹, E. S. Woodle¹

¹University of Cincinnati, Cincinnati, OH, ²Christ Hospital, Cincinnati, OH

Meeting: 2022 American Transplant Congress

Abstract number: 297

Keywords: Co-stimulation, Graft function, Immunosuppression, Outcome

Topic: Clinical Science » Kidney » 46 - Kidney Complications: Non-Immune Mediated Late Graft Failure

Session Information

Session Name: Kidney Complications: Non-Immune Mediated Late Graft Failure

Session Type: Rapid Fire Oral Abstract

Date: Monday, June 6, 2022

Session Time: 5:30pm-7:00pm

Presentation Time: 5:30pm-5:40pm

Location: Hynes Room 310

*Purpose: BENEFIT and BENEFIT EXT trials have demonstrated that belatacept-based immunosuppression was associated with improved long term renal allograft function compared to cyclosporine-based immunosuppression. Similar long-term data with tacrolimus as a comparator have not been reported to date. Herein we report comparison of long-term allograft function between belatacept-based regimens and a tacrolimus-based regimen.

*Methods: Five-year results from the two lead enrolling centers in a randomized multicenter trial were analyzed for renal function [SrCr, calculated eGFR (MDRD)] and immunologic events (BPAR and DSA). Slopes of eGFR and CKD stage were compared by treatment group over time. For analysis, eGFR was imputed as zero for missing values due to death or graft loss. Treatment groups received MMF and early steroid withdrawal with either ALEM/BELA, r-ATG/BELA, or r-ATG/TAC.

*Results: 168 patients with 5-year follow-up were analyzed by intention to treat (ITT). No demographic differences were observed by group. Five-year outcomes are reported in Table 1. Results of allograft function via slope-based analysis showed an overall decrease in mean eGFR from month 1 to month 60 in all treatment groups for ITT and censored for death and graft loss (Figure 1A, B). A similar analysis was performed based upon donor type, presence of BPAR or DSA (Figure 1C-H). The greatest eGFR decline was observed in patients experiencing BPAR or DSA. Higher CKD stages were reported in the r-ATG+TAC arm at all time points (Figure 2).

*Conclusions: Analysis of renal function using multiple approaches revealed: 1) all groups demonstrated a small progressive decline in eGFR out to five years 2) the negative slope of eGFR was greatest in patients with BPAR or DSA in all groups, and 3) the proportion of patients with eGFR <45 ml/min/1.73m² at 2 and 3 years was significantly higher in patients on tacrolimus and numerically higher at all time points compared to patients on belatacept. Longer follow-up is warranted to determine the renal function outcomes of belatacept compared to tacrolimus under early corticosteroid withdrawal.

To cite this abstract in AMA style:

Yanqui E, Hames H, Shields AR, Shi T, Christianson AL, Kremer J, Govil A, Alloway RR, Woodle ES. Renal Function at Five Years from a Randomized Multicenter Trial of Belatacept-Based CNI Free and Early Steroid Withdrawal Immunosuppression [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/renal-function-at-five-years-from-a-randomized-multicenter-trial-of-belatacept-based-cni-free-and-early-steroid-withdrawal-immunosuppression/. Accessed May 16, 2025.

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