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.
Viklicky, O., et al.Transplant International 2025; 38: 14312.
Aims
The aim of this study was to compare the effect of rabbit antithymocyte globulin (rATG) versus rATG plus intravenous immunoglobulins (IVIG) in kidney transplant recipients.
Interventions
Participants were randomly assigned to either the rATG/IVIG group or the rATG without IVIG group.
Participants
17 pre-sensitized kidney transplant recipients.
Outcomes
The primary endpoint was efficacy failure rate (defined as biopsy-proven antibody-mediated rejection (ABMR) and/or T-cell mediated rejection (TCMR). Secondary efficacy endpoints were the incidence of rejection at protocol biopsies, time to active ABMR, and the incidence of delayed graft function (DGF).
Follow-up
1 year
CET Conclusions
The inclusion of intravenous immunoglobulins (IVIG) in desensitisation protocols for HLA incompatible (HLAi) d kidney transplant is common despite a lack of strong evidence to support its use. This open-label randomised control trial aimed to investigate the utility of IVIG. Two desensitisation protocols for HLAi transplants were compared - combined IVIG/ATG (anti thymocyte globulin) vs ATG-alone. The primary outcome was the rate of biopsy-proven rejection at 12 months. The target recruitment was 138 patients, but the study was terminated after only 17 patients were enrolled because the rejection rate in the ATG group was 43% (n= 3/7). The authors concluded that IVIG-sparing desensitisation regimens are inferior and IVIG should continue to be used for HLAi kidney transplantation.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT04302805