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RECRUITING
NCT06919003
PHASE2

Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

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)

Official title: Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (RTB-021)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-09-22

Completion Date

2032-05-30

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

Berinert

Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft

OTHER

Placebo for Berinert

Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft

Locations (4)

Cedars Sinai Medical Center

Los Angeles, California, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Montefiore Medical Center

The Bronx, New York, United States