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
NCT Number: NCT06582485
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Ischemia-reperfusion Injury|Kidney Transplant; Complications
Sponsor: iCoat Medical AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2026-07

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.

Primary Outcome Measures: Delayed Graft Function (DGF), DGF is defined as the need for dialysis within the first 7 postoperative days., First 7 postoperative days.
Secondary Outcome Measures: eGFR over 12 months post transplantation, Estimated Glomerular Filtration Rate using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation with four (4) variables (serum creatinine, age, gender, and ethnicity), 12 months post transplantation|Primary non-function, Primary non-function (PNF) describes the condition in which the kidney never functions adequately after transplantation, and the patient continues to need dialysis despite the transplantation. The diagnosis of PNF generally does not become established before 2 to 3 months after transplantation. Assessed up to 12 months after transplantation, 12 months post transplantation|Number of Participants with prolonged DGF, Number of Participants with prolonged DGF (defined as requirement for dialysis more than 14 days post transplantation), 14 days post transplantation|Number of Participants with functional DGF, Number of Participants with functional DGF (defined as no serum creatinine decrease by at least 10% daily on 3 consecutive days within the first 7 days post-transplantation), First 7 days post-transplantation|Duration of dialysis sessions (hours), Duration of dialysis sessions within the first 30- and 90-days post-transplantation. Measured in hours., First 30- and 90-days post-transplantation|Number of dialysis sessions, Number of dialysis sessions within the first 30- and 90-days post-transplantation, First 30- and 90-days post-transplantation|Changes in Quality of Life, Quality of Life EuroQol - five dimensions - three levels (EQ-5D-3L) Assessed through standardized questionnaires, results combined to single summary index (0-1: 0 is death, 1 is perfect health)., 12 months post transplantation|Incidence of de novo Human Leukocyte Antigen (HLA) antibodies within 12 months, Incidence of de novo Human Leukocyte Antigen antibodies within 12 months, 12 months post transplantation|Incidence of biopsy-proven allograft rejection within 12 months, Incidence of biopsy-proven allograft rejection within 12 months, 12 months post transplantation|Tubular cell injury assessed by exploratory urinary biomarkers, Tubular cell injury assessed by exploratory urinary biomarkers; details not yet decided., 12 months post transplantation