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)
Participant must be able to understand and provide informed consent
Adults who are on chronic dialysis therapy and are on the wait list for deceased donor kidney transplant
Recipients who are ABO compatible with donor allograft
Negative crossmatch and no donor specific anti-HLA antibody (DSA) on most recent pretransplant serum sample as determined by local site
Inability or unwillingness of a participant to give written informed consent or comply with study protocol
Any prior or concurrent non-renal solid organ, or cellular transplant, or waitlisted for multi-organ transplant. Prior autologous transplant is allowed
Patients receiving enbloc kidneys
Kidneys that received ex vivo normothermic machine perfusion after procurement. Kidneys that received in situ normotherimic regional perfusion in the donor are eligible (see Inclusion #10)
Parallel
Berinert
Biological/VaccineAdministered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft
Placebo for Berinert
Other interventionAdministered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft
Difference 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
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.
Incidence of biopsy proven acute rejection (BPAR)
Incidence of proteinuria
Measured as spot urine protein/creatinine \>1 g/g
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.
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