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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
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.
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.
Delayed Graft Function (DGF)
DGF is defined as the need for dialysis within the first 7 postoperative days.
Time frame: First 7 postoperative days.
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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: First 30- and 90-days post-transplantation
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Number of dialysis sessions
Number of dialysis sessions within the first 30- and 90-days post-transplantation
Time frame: 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).
Time frame: 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
Time frame: 12 months post transplantation
Incidence of biopsy-proven allograft rejection within 12 months
Incidence of biopsy-proven allograft rejection within 12 months
Time frame: 12 months post transplantation
Tubular cell injury assessed by exploratory urinary biomarkers
Tubular cell injury assessed by exploratory urinary biomarkers; details not yet decided.
Time frame: 12 months post transplantation