One shot before transplant could save kidneys
NCT ID NCT06919003
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a single injection of Berinert, a protein that reduces inflammation, into a donor kidney just before transplant can improve kidney function in the first year. Researchers will compare this to a placebo in 180 high-risk patients receiving deceased-donor kidneys. The goal is to see if the treatment helps the kidney work better and reduces long-term damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Berinert (C1 esterase inhibitor)
- What this could lead to
- If it works, this could improve kidney function and reduce complications after transplant, potentially helping more donated kidneys last longer.
- What could go wrong
- This is a Phase 2 trial, so it's still early. The treatment may not improve outcomes, and there could be side effects from the injection or the drug itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant must be able to understand and provide informed consent 2. Adults who are on chronic dialysis therapy and are on the wait list for deceased donor kidney transplant 3. Recipients who are ABO compatible with donor allograft 4. Negative crossmatch and no donor specific anti-HLA antibody (DSA) on most recent pretransplant serum sample as determined by local site 5. Female participants of childbearing potential must have a negative pregnancy test upon study entry 6. 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 7. 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 8. 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 9. Recipients of kidneys arriving to the transplant center on ex vivo hypothermic machine perfusion pumps are eligible 10. Recipients of kidneys that received in situ normothermic regional perfusion in the donor are eligible. Kidneys that received normothermic machine perfusion after organ procurement (ex situ normothermic perfusion) are not eligible (See Exclusion #4) 11. Anticipated Cold Ischemia Time (CIT) \>=12 hours 12. Kidney Donor Profile Index (KDPI) 21-95%. For KDPI 21-34% to be eligible, anticipated CIT must be \>=24 hours 13. Patients with normal coagulation Exclusion Criteria: 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol 2. Any prior or concurrent non-renal solid organ, or cellular transplant, or waitlisted for multi-organ transplant. Prior autologous transplant is allowed 3. Patients receiving enbloc kidneys 4. Kidneys that received ex vivo normothermic machine perfusion after procurement. Kidneys that received in situ normotherimic regional perfusion in the donor are eligible (see Inclusion #10) 5. Patients with a known pro-thrombotic disorder 6. Patients with a history of thrombosis or hyper-coagulable state, excluding dialysis access clotting or other superficial vein thrombosis not requiring long-term systemic treatment 7. Body mass index (BMI) \>=40 kg/m\^2 8. 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 9. Patients with a known hypersensitivity to treatment with Berinert 10. Patients requiring chronic anti-coagulation or anti-platelet therapy. ASA and NSAIDS are allowed 11. 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, renal cell carcinoma stage T1N0M0 that has been treated with nephrectomy, or adequately treated basal or squamous cell carcinoma of the skin 12. Patients who are positive for Hep B infection (Hepatitis B surface antigen (HBsAg)+); patients with HbcAB+ are eligible if HBV PCR is negative 13. Any active infection 14. Human immunodeficiency virus (HIV) infection 15. Enrollment in another investigational trial 16. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment 17. Current or planned use of immunomodulatory agents including but not limited to rituximab, belatacept, eculizumab, JAK inhibitors, anti-TNF agents 18. Female participants who are pregnant or lactating 19. 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 20. History of any stroke (including ischemic, hemorrhagic, or embolic) within the previous 6 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Kansas University Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467-2401, United States
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Northwestern Memorial Hospital
RECRUITINGChicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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- 30,000 dialysis patients tracked to map what works
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