Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)

Phase 2 Completed 68 enrolled Prof. Dr. Petra Reinke Institut Klinické a Experimentální Medicíny · collab

NaSingle-groupOpen-labelTreatment

Summary

International multicenter open-label single-arm confidence-interval-estimation based Phase II clinical trial, aiming to estimate a plausible range of the proportion of patients experiencing efficacy failure in the population, to provide evidence for efficacy and safety of the induction regimen with rATG and infliximab and a go/no go rule for further clinical development.

Timeline

Start: 2016-12-15
Primary completion: 2020-12
Completion: 2020-12-31

Outcome

Met primary endpoint

paper Primary endpoint occurred in 22 of 67 patients (32.84%), with upper bound of an exact 1-sided 95% CI of 43.47%, which met the predefined criteria PMID 37525369 ↗

Publications

Viklicky O, Zahradka I, Bold G, Bestard O, Hruba P, Otto NM, Stein M, Sefrin A, Modos I, Meneghini M, Crespo E, Grinyo J, Volk HD, Christakoudi S, Reinke P. Tacrolimus After rATG and Infliximab Induction Immunosuppression-RIMINI Trial. Transplantation. 2024 Jan 1;108(1):242-251. doi: 10.1097/TP.0000000000004736. Epub 2023 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	5 mg/kg	—
Subject	rabbit anti-thymocyte globulin	Protein / enzyme biologic	1.5 mg/kg	—
Background	Prednisolone	Other / unclassified	5 mg	—
Background	Tacrolimus	Small molecule	0.2 mg/kg	—