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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06919003
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Berinert — BIOLOGICAL
    Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft
  • Placebo for Berinert — OTHER
    Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft

Study Details

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)

Key Dates

Start date
Sep 22, 2025
Status verified
Feb 2026
Primary completion
May 30, 2031
Completion
May 30, 2032

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Berinert
  • Placebo Comparator: Saline

Primary Outcome Measure

Difference between study arms in renal function [ Time Frame: At 12-months post-transplantation ]

Locations (4)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Tillie Morrisette
[email protected]
424-315-1316
Andrea Calderon
[email protected]
310-423-2319
Northwestern Memorial HospitalChicagoIllinois60611
Laura Adams
[email protected]
312-694-0242
Kansas University Medical CenterKansas CityKansas66160
Adam Schooey
[email protected]
913-588-1699
Montefiore Medical CenterThe BronxNew York10467-2401
Harith Raees
[email protected]
929-285-4339

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CANorthwestern Memorial Hospital· Chicago, ILKansas University Medical Center· Kansas City, KSMontefiore Medical Center· The Bronx, NY

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