Abstract
Background:Two prospective studies that were performed before the era of highly sensitive solid-phaseassays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patientsgiven polyclonal antibodies compared with those given anti-CD25 monoclonal antibodies.Methods:This prospective pilot randomized French multicenter study aimed to compare anti–T-lympho-cyte Ig (ATLG) (n¼32) and basiliximab (n¼27) in highly sensitized kidney-transplant patients withoutpreformed donor-specific antibodies (pDSAs) as assessed by a Luminex Single-Antigenflow bead assay.Only patients with a calculated panel reactive antibody$50%, with at least 1 antibody with a meanfluorescence intensity$5000 and without a historical pDSA and without a pDSA on the day of trans-plantation 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% confidence interval [CI], 8.9%–37.1%) and 18.8% (95% CI, 8.9%–37.1%) in patients who received ATLG and 14.8% (95% CI, 5.8%–34.8%) and 28.2% (95% CI, 14.2%–51.2%) ofpatients who received basiliximab, respectively at 6 (P¼0.66) and 12 (P¼0.62) months post-transplantation.One T cell–mediated rejection was observed in ATLG-treated patients (3.1%). One antibody-mediatedrejection due to ade novodonor-specific antibody (DSA) occurred in basiliximab-treated patients (3.7%).Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 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, because of the lack of power,these results should be interpreted with caution