NCT06582485

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

A Randomized, Placebo-controlled, Double-blind Phase 2b Trial to Assess the Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg/mL to Improve Allograft Function in Recipients of Donation After Circulatory Death Kidneys

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: iCoat Medical AB · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The present trial aims to evaluate if iCM012 solution 2 mg/mL can improve short and mid-term allograft function of controlled donation after circulatory death (DCD) kidneys at high risk for Ischemia Reperfusion Injury (IRI) -induced graft dysfunction as assessed by primarily DGF and secondary as estimated glomerular filtration rates (eGFR). The trial will also generate additional efficacy, safety, and exploratory data.

Conditions

• Ischemia-reperfusion Injury
• Kidney Transplant; Complications

Interventions

Type	Name	Description
DRUG	iCM012 solution 2 mg/mL	200 mL IMP solution is administered ex vivo by gravity as single infusion through the renal artery/-ies over a period of 5-10 minutes.
DRUG	Placebo	200 mL IMP solution is administered ex vivo by gravity as single infusion through the renal artery/-ies over a period of 5-10 minutes.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-09-03
• Last updated: 2025-04-03