Status:
RECRUITING
Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Kidney Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 recipien...
Eligibility Criteria
Inclusion
- Participant must be able to understand and provide informed consent
- Adults who are on chronic dialysis therapy and are on the wait list for deceased donor kidney transplant
- Recipients who are ABO compatible with donor allograft
- Negative crossmatch and no donor specific anti-HLA antibody (DSA) on most recent pretransplant serum sample as determined by local site
- Female participants of childbearing potential must have a negative pregnancy test upon study entry
- All participants with reproductive potential must agree to use highly effective contraception for at least 12-moths post-transplant. Oral estrogen containing contraception must not be used during the first 3 months post-transplant
- Hepatitis C Virus Ab positive participants with negative Hepatitis C virus (HCV) Polymerase chain reaction (PCR) are eligible if they have spontaneously cleared infection or are in sustained virologic remission
- Hepatitis C Virus negative recipients of a Hepatitis C Virus positive organ are eligible if they will be treated with the intent of inducing a sustained virologic remission
- Recipients of kidneys arriving to the transplant center on ex vivo hypothermic machine perfusion pumps are eligible
- Vaccines up to date per Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials
- Anticipated Cold Ischemia Time (CIT) \>=12 hours
- Kidney Donor Profile Index (KDPI) 21-95%. For KDPI 21-34% to be eligible, anticipated CIT must be \>=24 hours
- Patients with normal coagulation
Exclusion
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Any prior or concurrent non-renal solid organ, or cellular transplant, or waitlisted for multi-organ transplant
- Patients receiving enbloc kidneys
- Kidneys receiving normothermic perfusion
- Patients with a known pro-thrombotic disorder
- Patients with a history of thrombosis or hyper-coagulable state, excluding dialysis access clotting
- Body mass index (BMI) \>=40 kg/m\^2
- Patients with a history of Hereditary Angioedema or use of C1 esterase inhibitor (C1INH) containing products or recombinant C1INH within 15 days prior to study entry
- Patients with a known hypersensitivity to treatment with Berinert
- Patients requiring chronic anti-coagulation or anti-platelet therapy. ASA and NSAIDS are allowed
- Presence of active malignancy or history of malignancy less than 5 years in remission, excluding adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin
- Patients who are positive for Hep B infection (Hepatitis B surface antigen (HBsAg)+ or anti-HBcore +)
- Any active infection
- Human immunodeficiency virus (HIV) infection
- Enrollment in another investigational trial
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
- Current or planned use of immunomodulatory agents including but not limited to rituximab, belatacept, eculizumab, JAK inhibitors, anti-TNF agents
- Female participants who are pregnant or lactating
- Past or current medical problems, inclusive of mental health and substance abuse concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2032
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06919003
Start Date
September 22 2025
End Date
May 30 2032
Last Update
September 26 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
3
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
4
Montefiore Medical Center
The Bronx, New York, United States, 10467-2401