CompletedPhase 1/2

C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI

United States70 participantsStarted 2014-09

Plain-language summary

The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with high risk for delayed graft function (DGF) may show significant improvement in outcomes post transplant compared with patients that do not receive C1INH treatment. Complement activation has been detected in animal models and human kidneys with ischemic reperfusion injury (IRI) and inflammatory cell infiltrates. By blocking complement activation the investigators hope to improve kidney graft function post transplant in these recipients.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-70 yrs of age; recipient of ECD/DCD/ECD\&DCD with risk index 3-8 for DGF based on specific criteria * recipient who are ABO compatible with donor allograft * pretransplant with meningococcal vaccination * understand and sign a written consent prior to any study specific procedure. Risk index (minimum 3- maximum 8): DGF scale: Donor Age (\<40yr = 0, 41-49yr = 1, 50-54yr = 2, 55-59yr = 3, \>60yr=6), Cold Ischemia Time (0-12= 0, 13-18=1, 19-24=2, 24-30=3, 31-36=4, \>37=6; Recipient Race (nonblack = 0, black =1); Donor death due to Cerebrovascular Accident (CVA) (donor age \<50yrs = 0, donor age \>50yrs = 3). Exclusion Criteria: * patients with known prothrombotic disorder (e.g. factor V leiden) * history of thrombosis or hypercoagulable state excluding access clotting * history of administration of C1INH containing products or recombinant C1INH within 15 days prior to study entry * patients with known contraindication to treatment with C1INH * patients with abnormal coagulation function (INR \>2, partial thromboplastin time (PTT) \> 50, platelets \<80,000) * who are not on anti-coagulation * patients with known active presence of malignancies * Polymerase chain reaction (PCR) positive for hep B/hep C/or HIV * preemptive kidney transplantation recipient * recipients of multi-organ transplants (kidney and any other organ) * recipients of kidney allograft from DD who: cold ischemia time (CIT) \<18h, terminal serum creatinine \</= 1mg/dl, recipient of k…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.

Timeframe: First 7 days post-transplant

Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.

Timeframe: First 7 days post-transplant

Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.

Timeframe: First 7 days post-transplant

Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.

Timeframe: First 7 days post-transplant

Trial details

NCT IDNCT02134314

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03-13

Results submitted2018-03-13

View on ClinicalTrials.gov More End Stage Renal Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.

Timeframe: First 7 days post-transplant

Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.

Timeframe: First 7 days post-transplant

Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.

Timeframe: First 7 days post-transplant

Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.

Timeframe: First 7 days post-transplant