Abstract: SA-PO503

A Randomized Controlled Trial Comparing Belatacept to Tacrolimus in De Novo Kidney Transplantation

Session Information

Category: Transplantation

  • 1702 Transplantation: Clinical and Translational

Authors

  • De Graav, Gretchen Norine, Erasmus MC, Rotterdam, Netherlands
  • Baan, Carla, Erasmus MC, Rotterdam, Netherlands
  • Clahsen - van Groningen, Marian, Erasmus MC, Rotterdam, Netherlands
  • Von der thüsen, Jan H, Erasmus MC, Rotterdam, Netherlands
  • Cadogan, Monique, Erasmus MC, Rotterdam, Netherlands
  • Van De Wetering, Jacqueline, Erasmus MC, Rotterdam, Netherlands
  • van Rosmalen, Joost, Erasmus MC, Rotterdam, Netherlands
  • Weimar, Willem, Erasmus MC, Rotterdam, Netherlands
  • Hesselink, Dennis Alexander, Erasmus MC, Rotterdam, Netherlands
Background

Belatacept (bela) allows for calcineurin-inhibitor-free immunosuppressive therapy after kidney transplantation but is associated with a higher acute rejection risk than ciclosporin. We compared clinical outcomes in a randomized-controlled trial comparing bela to tacrolimus (tac) in de novo kidney transplantation.

Methods

Forty kidney transplant recipients were 1:1 randomized to a bela- or tac-based immunosuppressive regimen combined with basiliximab, mycophenolate, and prednisolone. One-year graft- and biopsy-proven acute rejection (BPAR)-free survival were assessed, as well as the development of de novo donor-specific anti-HLA antibodies (DSA), the incidence of adverse events (AEs) and eGFR (in mL/min/1.73m2).

Results

Three graft losses occurred on days 12, 59, and 161 after transplantation, resulting in a 1-year death-censored graft survival of 85% in the belatacept group vs. 100% in the tacrolimus group (p=0.08). All were the result of glucocorticoid-resistant rejection. The incidence of BPAR was higher in the bela-treated than in the tac-treated patients, n=11 (55%) vs. n=2 (10%), p=0.006, respectively, and rejections were of a more severe grade. In the first year, 2 patients, of which 1 rejected, developed DSA, both in the bela group. Total AEs were similar between groups; means of 10.3 and 11.9 per patient in the bela- and tac-groups, respectively, p=0.41. Post-transplant diabetes mellitus occurred more often in the tacrolimus group; n=7 vs. n=1 in the belatacept group, p=0.04. eGFR, excluding graft losses, was not different between bela-treated and tac-treated patients on month 12: 54 (28–89) and 50 (33–84) mL/min, respectively; p=0.57. However, graft-loss censored eGFR in bela-treated rejectors (n=8) was 36 (28-76) mL/min at month 12, which was lower than the eGFR of 58 (37-84) mL/min in the bela-treated non-rejectors, p=0.001.

Conclusion

Bela-based immunosuppressive therapy results in a higher rejection rate and severity compared to standard, tac-based therapy, and shows similar graft function 1 year after transplantation.