A randomized prospective study comparing anti-T lymphocyte immunoglobulins to basiliximab in highly sensitized kidney-transplant patients

Abstract Background 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. Methods This prospective pilot randomized French multicenter study aimed to compare anti-T lymphocyte immunoglobulin (ATLG) (n=32) and basiliximab (n=27) in highly sensitized kidney-transplant patients without preformed donor specific antibodies (pDSAs) as assessed by a Luminex Single Antigen flow bead assay. 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 18.8% (95%CI=[8.9%-37.1%]) and 18.8% [8.9%-37.1%] in patients who received ATLG and 14.8% [5.8%-34.8%] and 28.2% [14.2%-51.2%] of patients who received basiliximab, respectively at 6 (p=0.66) and 12 (p=0.62) months post-transplantation. One T-cell mediated rejection was observed in ATLG-treated patients (3.1%). One antibody-mediated rejection due to a de novo DSA occurred in basiliximab-treated patients (3.7%). Patient survival, graft survival, kidney parameters, and infection rate, were similar in the two groups. Conclusion This pilot study indicates that in highly-sensitized kidney-transplant patients without pDSAs, both ATLG and basiliximab can be used efficiently and safely. However, due to the lack of power, these results should be interpreted with caution.