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New treatment option for Kidney Transplant
Official title Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)
ClinicalTrials.gov ID: NCT06919003
What this study is testing
What is Berinert?
Berinert is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kidney transplant.
Also referred to as C1 esterase inhibitor, C1INH.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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. Prior autologous transplant is...
- Patients receiving enbloc kidneys
- Kidneys that received ex vivo normothermic machine perfusion after procurement. Kidneys that received in situ normotherimic regional perfusion in the...
- Patients with a known pro-thrombotic disorder
- Patients with a history of thrombosis or hyper-coagulable state, excluding dialysis access clotting or other superficial vein thrombosis not...
See the full eligibility criteria
- 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...
- 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
- 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...
- 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
- 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. Prior autologous transplant is allowed
- Patients receiving enbloc kidneys
- 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)
- Patients with a known pro-thrombotic disorder
- 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
- 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, renal cell carcinoma stage T1N0M0 that has...
- Patients who are positive for Hep B infection (Hepatitis B surface antigen (HBsAg)+); patients with HbcAB+ are eligible if HBV PCR is negative
- 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...
- History of any stroke (including ischemic, hemorrhagic, or embolic) within the previous 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Chicago, Illinois, United States; Kansas City, Kansas, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.