rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)

Phase 3 Completed 17 enrolled Institute for Clinical and Experimental Medicine

RandomizedParallel-groupOpen-labelPrevention

Summary

This study aims to prove similar efficacy of PE/rATG (intervention) and PE/rATG/IVIG (centre standard of care) induction regimens to prevent biopsy proven antibody-mediated changes and TCMR as composite endpoint within 12 months after HLA incompatible kidney transplantation.

Timeline

Start: 2020-07-27
Primary completion: 2024-04-15
Completion: 2024-06-15

Publications

Viklicky O, Zahradka I, Mares J, Slatinska J, Parikova A, Petr V, Roder M, Jaklova K, Osickova K, Janousek L, Hruba P. 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. Transpl Int. 2025 May 19;38:14312. doi: 10.3389/ti.2025.14312. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.5 g/kg	Intravenous
Comparator	Thymoglobulin	Protein / enzyme biologic	1 mg/kg	—

Indications

No indication recorded.