Actively Recruiting
Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-02-27
180
Participants Needed
4
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Adults on chronic dialysis therapy listed for deceased donor kidney transplant
- ABO compatible with donor kidney
- Negative crossmatch and no donor specific anti-HLA antibody on recent pretransplant serum
- Female participants of childbearing potential must have a negative pregnancy test at study entry
- Agree to use effective contraception for at least 12 months post-transplant; no oral estrogen contraceptives for first 3 months
- Hepatitis C antibody positive with negative PCR or treated to remission are eligible
- Hepatitis C negative recipients of Hepatitis C positive organs if treated to remission are eligible
- Recipients of kidneys arriving on ex vivo hypothermic machine perfusion pumps are eligible
- Recipients of kidneys with in situ normothermic regional perfusion in donor are eligible; ex situ normothermic perfusion after procurement are not eligible
- Anticipated cold ischemia time of 12 hours or more
- Kidney Donor Profile Index between 21-95%; for 21-34%, cold ischemia time must be 24 hours or more
- Normal coagulation
You will not qualify if you...
- Unable or unwilling to give informed consent or follow study protocol
- Prior or current non-renal solid organ or cellular transplant or waiting for multi-organ transplant; prior autologous transplant allowed
- Receiving enbloc kidneys
- Kidneys that received ex vivo normothermic machine perfusion after procurement
- Known pro-thrombotic disorder
- History of thrombosis or hyper-coagulable state except minor vein thrombosis not needing long-term treatment
- Body mass index 40 kg/m2 or higher
- History of Hereditary Angioedema or use of C1 esterase inhibitor products within 15 days before study
- Known allergy to Berinert
- Need for chronic anticoagulation or antiplatelet therapy (except ASA and NSAIDS)
- Active cancer or cancer remission less than 5 years except certain treated cancers
- Positive Hepatitis B surface antigen; Hepatitis B core antibody positive with negative PCR allowed
- Active infection
- HIV infection
- Participation in another investigational trial
- Recent live attenuated vaccine within 4 weeks
- Current or planned use of certain immunomodulatory drugs
- Pregnant or lactating females
- Medical or mental health problems or lab findings that pose additional risks or affect compliance
- Stroke within 6 months prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
4
Montefiore Medical Center
The Bronx, New York, United States, 10467-2401
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here