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 range18 Years – 70 Years

SexALL

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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…

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 range18 Years – 70 Years

SexALL

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