A Trial to Assess Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg/ml to Improve Its Function in Recipients of DCD Kidneys

Phase 2/3 Not yet recruiting 200 enrolled iCoat Medical AB

RandomizedParallel-groupTriple-blindTreatment

Summary

Randomized (1:1), placebo controlled, double blind efficacy trial. 200 patients will be followed up for 12 months post transplantation. The primary endpoint will be Delayed Graft Function (DGF) defined as the requirement for dialysis within 7 days post transplantation.

Timeline

Start: 2025-09
Primary completion: 2026-12
Completion: 2026-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	iCM012	Unknown	2 mg/ml	Other
Subject	iCM012	Unknown	200 ml	Other

A Trial to Assess Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg/ml to Improve Its Function in Recipients of DCD Kidneys

Summary

Timeline

Drugs

Indications