AUTHOR=Viklicky Ondrej , Zahradka Ivan , Mares Jan , Slatinska Janka , Parikova Alena , Petr Vojtech , Roder Matej , Jaklova Katerina , Osickova Klara , Janousek Libor , Hruba Petra 

TITLE=12-Month Outcomes of a Prospective Randomized Trial Investigating Effects of IVIG on Top of rATG Versus rATG Alone in Pre-Sensitized Kidney Transplant Recipients: The INHIBIT Study

JOURNAL=Transplant International

VOLUME=Volume 38 - 2025

YEAR=2025

URL=https://www.frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2025.14312

DOI=10.3389/ti.2025.14312

ISSN=1432-2277

ABSTRACT=Intravenous immunoglobulins (IVIG) are commonly used in peri-transplant desensitization, but evidence supporting their efficacy is limited. We conducted a prospective, randomized single-center, open-label, non-inferiority clinical trial to compare the efficacy of IVIG (administered at a dose of 3x0.5g/kg) versus no IVIG, in conjunction with rabbit anti-thymocyte globulin (5-7mg/kg) induction, in presensitized patients with donor-specific antibodies who had negative pre-transplantation Flow-and CDC-crossmatches, between July 2020 and November 2022. The primary endpoint was the rate of efficacy failure, defined as biopsy-proven rejection within 12months post-transplant. Secondary endpoints included the incidence of rejection at protocol biopsies, evaluated by histology and biopsy-based transcripts diagnostics. Of the screened patients, 53 (72.6%) were excluded due to crossmatch positivity. Ten patients were randomized to the IVIG+, and 7 to the IVIG-arm. The trial was prematurely terminated due to futility at interim analysis. In the IVIG-arm, 3 patients (43%) experienced the primary endpoint compared to none in the IVIG+ arm (p=0.026). MMDx identified one molecular ABMR in the IVIG+ and 2 in the IVIG-arm in 12-month protocol biopsies. There was one graft loss in the IVIG-arm. The results of this pilot study, although not definitive, do not support the use of IVIG-sparing regimens in HLAincompatible kidney transplantation (NCT04302805).