A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs 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 with those given anti-CD25 monoclonal antibodies. Methods: This prospective pilot randomized French multicenter study aimed to compare anti-T-lymphocyte Ig (ATLG) (n ¼ 32) and basiliximab (n ¼ 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 calculated panel reactive antibody $50%, with at least 1 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% 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%) of patients who received basiliximab, respectively at 6 (P ¼ 0.66) and 12 (P ¼ 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 donor-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.

One-Year Outcomes with Use of Anti-T-Lymphocyte Globulin in Patients Undergoing Kidney Transplantation: Results from a Prospective, Multicentric, Observational Study from India

“…Using a regimen of 9 mg/kg prior to reperfusion of the allograft, followed by 3 mg/kg/day on day 1 to 4, a randomized study from Switzerland reported ABMR and ACR rate of 35% and 11% within 1 year of transplantation [ 23 ]. With similar dosing regime, Kamar et al observed BPAR and graft loss rate of 3.6% and 9.6% at 1 year [ 15 ]. These data indicate that ATLG is effective in reducing acute rejection and improving graft survival.…”

“…Initial studies from India have shown equivalent patient survival and death-censored graft survival with ATLG and ATG [12]. Compared to basiliximab, ATLG has similar rates of biopsy-proven acute rejection (BPAR) and acute graft rejection [15]. However, rates of delayed graft function and need for dialysis were lower with ATLG than basiliximab [16].…”