*Purpose: Two prospective studies that were performed before the era of highly sensitive solid-phase assays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patients given polyclonal antibodies compared to those given anti-CD25 monoclonal antibodies. The aim of this prospective pilot randomized French multicenter study was to compare anti-T lymphocyte immunoglobulin (ATLG) and basiliximab in highly sensitized kidney-transplant patients.

*Methods: Highly sensitized kidney-transplant patients without preformed donor specific antibodies (pDSAs) as assessed by a Luminex Single Antigen flow bead assay were given ATLG (n=32) or basiliximab (n=27) Only patients with a cPRA ≥ 50%, with at least one antibody with a mean fluorescence intensity ≥ 5000 and without a historical pDSA and without a pDSA on the day of transplantation were included.

*Results: Treatment failure as defined by biopsy-proven acute rejection, patient lost to follow-up, graft loss and death was observed in 18.7% (95%CI=[8.9%-37%]) and 23.8% [11.9%-44.4%] in patients who received ATLG and 29.6% [16.1%-50.6%] and 36% [20.1%-58.9%] of patients who received basiliximab, respectively at 6 (p=0.4) and 12 (p=0.4) months post-transplantation. One T-cell mediated rejection and one borderline rejection were observed in ATLG-treated patients (6.3%). One antibody-mediated rejection and 4 borderline rejections occurred in basiliximab-treated patients (18.5%). Only one patient who received basiliximab developed a de novo DSA. Patient survival, graft survival, kidney function, histological lesions observed on protocol kidney biopsy, infection rate, and immunosuppressant tolerance were similar in the two groups.

*Conclusions: In conclusion, this pilot study indicates that in highly-sensitized kidney-transplant patients without pDSAs, both ATLG and basiliximab can be used efficiently and safely.

« Back to 2020 American Transplant Congress