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NCT06919003 · ClinicalTrials.gov registry record · Phase 2
Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)
A Phase 2 study of Kidney Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 4
- Study locations
NCT06919003 is a Phase 2 study of Kidney Transplant that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, below the 1,892-participant average among 30 other Kidney Transplant trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT06919003, a Phase 2 study of Kidney Transplant, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 4
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL Berinert
- OTHER Placebo for Berinert
Study Locations (4)
California
- Cedars Sinai Medical Center - Los Angeles
Illinois
- Northwestern Memorial Hospital - Chicago
Kansas
- Kansas University Medical Center - Kansas City
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-09-22 |
| Est. Completion | 2032-05-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06919003
The ClinicalTrials.gov registry entry for NCT06919003 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,892-participant average among 30 other Kidney Transplant trials with a reported enrollment target (90% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Kidney Transplant appearing as the primary indexed condition, and to 2 interventions - of which Berinert is the first listed.
NCT06919003 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT06919003 about?
NCT06919003 is a clinical study titled "Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)". 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...
What is the current status of trial NCT06919003?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2025-09-22. Estimated completion is 2032-05-30.
What conditions does trial NCT06919003 study?
This clinical trial studies the following conditions: Kidney Transplant.
What interventions are being tested in trial NCT06919003?
The interventions under investigation include: Berinert (BIOLOGICAL), Placebo for Berinert (OTHER).
Who is sponsoring clinical trial NCT06919003?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06919003 being conducted?
This trial has 4 study locations across California, Illinois, Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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