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

• Status: Completed
• Trial end date: 2017-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

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 creatininepreservation for any period prior to transplantation, recipient of kidney allograft from a living donor, female subject who are pregnant or lactating.