A Randomized Prospective Study Comparing Anti-T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients.Kamar, N., et al.
KI Reports 2020; 5(8): 1207-1217.
This study aimed to compare the efficacy and safety of anti–T-lymphocyte Ig (ATLG) versus basiliximab in highly sensitized renal transplant recipients.
Patients were randomly assigned at a 1:1 ratio to either ALTG or basiliximab.
59 kidney transplant patients.
The primary outcome was treatment failure, which was defined by acute rejection (biopsy-proven), loss to follow-up, graft loss and/or death at 6 months. The secondary outcomes were the analyses of primary outcomes at 6 and 12 months, histological findings on protocol kidney biopsies and the incidence of de novo donor-specific antibody (DSA) post-transplantation. The safety outcomes included viral complications and hematological parameters.
This is an open-label RCT of 2 induction antibody regimens for highly sensitized renal transplant recipients. The study was centrally randomized and stratified by center. It was a small study, including 59 patients and had no prior power calculation. The primary outcome was a composite of Biopsy Proven Acute Rejection (BPAR), loss to follow up, graft loss, death, and was not found to be significantly different between the study arms at 6 months follow up. At 12 months of follow up there was a difference in the rate of primary outcome of 19% with ATG and 28% with Basiliximab, but this was not statistically significant in this small study. The number of patients with BPAR in both groups was actually very low (only 1 each); this was TCMR in the ATG group and ABMR in the Basiliximab group. There was no significant difference in adverse events or rate of infection. There were no cases of PTLD, but 2 patients in the ATG group developed cancer during the follow up period (skin cancer and native renal cancer). The study is too small on its own to conclusively say that these two induction antibodies can be used with equal benefit and risk in this population
ClinicalTrials.gov - NCT02377193