NCT06919003

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-22
• Primary completion: 2031-05-30
• Completion: 2032-05-30
• First posted: 2025-04-09
• Last updated: 2026-02-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study