The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient. This research study will compare Berinert to placebo. The placebo looks exactly like Berinert but does not contain any active drug. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Neither you or the study doctor can choose or know which group is assigned. The primary objective is to test whether intrarenal artery C1 esterase inhibitor (C1INH) injection into the donor kidney prior to transplantation improves kidney function in recipients of high risk, deceased donor kidney transplants as measured by 12-month Estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft
Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft
Cedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGNorthwestern Memorial Hospital
Chicago, Illinois, United States
RECRUITINGKansas University Medical Center
Kansas City, Kansas, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGDifference between study arms in renal function
Measured as Estimated Glomerular Filtration Rate Chronic Kidney Disease Epidemiology Collaboration (eGFRCKD-EPI) in ml/min/1.73m\^2
Time frame: At 12-months post-transplantation
Comparison between the treated and control group of the full iBox score
The iBox scoring system is a composite biomarker panel. The full iBox scoring system consists of 4 elements all obtained 1-year post-transplant: a) eGFR (MDRD), b) DSA, c) urinary protein/creatine ratio, and d) histological abnormalities on a surveillance biopsy.
Time frame: At 12-months post-transplantation
Incidence of biopsy proven acute rejection (BPAR)
Time frame: At 12-months post-transplantation
Incidence of proteinuria
Measured as spot urine protein/creatinine \>1 g/g
Time frame: At 12-months post-transplantation
Incidence of de novo donor specific anti-Human Leukocyte Antigen (HLA) antibody (DSA)
Defined as the incidence of de novo DSA on standard of care or protocol directed blood draws up to and including the 12-month protocol blood draw.
Time frame: At 12-months post-transplantation
Incidence of Grade 3 or higher infections
Time frame: At 12-months post-transplantation
Incidence of Grade 3 or higher intraoperative or postoperative hemorrhage
Time frame: Within 4 weeks after transplantation
Incidence of thrombotic or thromboembolic events
Excluding superficial thrombophlebitis, catheter-related thrombosis and dialysis access thrombosis
Time frame: Within 4 weeks after transplantation
Incidence of T cell mediated rejection (TCMR) that is steroid resistant
Time frame: At 12-months post-transplantation
Incidence of TCMR that is BANFF grade 2 or higher
Time frame: At 12-months post-transplantation
Incidence of antibody mediated rejection (ABMR)
Time frame: At 12-months post-transplantation
Incidence of death
Time frame: At 12-months post-transplantation
Incidence of Graft loss (including primary non function)
Time frame: At 12-months post-transplantation
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