Status: Not yet recruiting
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
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.
Participants needed: 200
Trial details
Phase: Phase 2, Phase 3Age: 55-75Biological sex: AllType: InterventionalSponsor: iCoat Medical ABUpdated: Apr 3, 2025
Eligibility criteria
Controlled DCD donors Maastricht category III from 55 to 75 years of age. [+4]
Surgically induced injuries or anatomical vascular variations compromising ex vi... [+16]