Phase 2
N=70
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
End Stage Renal Disease · Kidney Failure · Delayed Graft Function · Ischemic Reperfusion Injury
Bottom Line
View on ClinicalTrials.gov: NCT02134314 ↗Enrolled (actual)
70
Serious AEs
28.6%
Results posted
Jun 2018
Primary outcome: Primary: Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. — 29; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- C1 Esterase Inhibitor (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. |
29; 32 | — |
| PRIMARY Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. |
15; 21 | — |
| PRIMARY Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. |
30; 28 | — |
| PRIMARY Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. |
0.97; 1.54 | — |
| SECONDARY Serum Creatinine |
1.3; 1.7 | — |
| SECONDARY Creatinine Clearance |
56.4; 51.2 | — |
| SECONDARY 24h Urine Output |
873.5; 607.8 | — |
| SECONDARY Mean Number of Patients on Dialysis |
0; 5 | — |
| SECONDARY Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale) |
15; 21 | — |
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.
Eligibility 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 ( 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 = 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 kidney allograft that was on pump preservation for any period prior to transplantation, recipient of kidney allograft from a living donor, female subject who are pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT02134314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.