End Stage Renal Disease Clinical Trial
— C1INHDGFOfficial title:
Assessing Safety and Efficacy of Preoperative and Post-Transplant C1 Inhibitor (Berinert®) vs. Placebo in Recipients of a Renal Allograft From Deceased High Risk Donors and Its Impact on DGF and IRI
Verified date | June 2018 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 13, 2017 |
Est. primary completion date | March 13, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Castellano G, Melchiorre R, Loverre A, Ditonno P, Montinaro V, Rossini M, Divella C, Battaglia M, Lucarelli G, Annunziata G, Palazzo S, Selvaggi FP, Staffieri F, Crovace A, Daha MR, Mannesse M, van Wetering S, Paolo Schena F, Grandaliano G. Therapeutic targeting of classical and lectin pathways of complement protects from ischemia-reperfusion-induced renal damage. Am J Pathol. 2010 Apr;176(4):1648-59. doi: 10.2353/ajpath.2010.090276. Epub 2010 Feb 11. — View Citation
Dalle Lucca JJ, Li Y, Simovic M, Pusateri AE, Falabella M, Dubick MA, Tsokos GC. Effects of C1 inhibitor on tissue damage in a porcine model of controlled hemorrhage. Shock. 2012 Jul;38(1):82-91. doi: 10.1097/SHK.0b013e31825a3522. — View Citation
Giral-Classe M, Hourmant M, Cantarovich D, Dantal J, Blancho G, Daguin P, Ancelet D, Soulillou JP. Delayed graft function of more than six days strongly decreases long-term survival of transplanted kidneys. Kidney Int. 1998 Sep;54(3):972-8. — View Citation
Pascual J, Zamora J, Pirsch JD. A systematic review of kidney transplantation from expanded criteria donors. Am J Kidney Dis. 2008 Sep;52(3):553-86. doi: 10.1053/j.ajkd.2008.06.005. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall Incidence of Serious Adverse Events | Overall incidence of serious adverse events in the C1INH and placebo groups, number of events. | Up to 9 months post-transplant | |
Other | Patient Survival | Patient survival at 90 days post-transplantation | Up to 90 days post-transplant | |
Other | Rate of Acute Cellular Rejection (ACR) | Number of acute cellular and antibody mediated rejection episodes by day 90. | Up to 90 days post-transplant | |
Other | Graft Survival | Number of Participants with Graft Survival at 90 Days Post-Transplant | Day 90 Post-transplant | |
Primary | Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | Number of participants in the C1INH and placebo groups with serum creatinine >3mg/dL on postoperative day 5 | First 7 days post-transplant | |
Primary | Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia). | First 7 days post-transplant | |
Primary | Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | Number of patients in the C1INH and placebo groups with serum creatinine reduction of < 30% from 24 to 48 hours post-transplant. | First 7 days post-transplant | |
Primary | Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. | Mean quantity of dialysis sessions per patient in the first 7 days post transplant. | First 7 days post-transplant | |
Secondary | Serum Creatinine | Mean serum creatinine on day 90 in mg/dL | Up to 90 days post-transplant | |
Secondary | Creatinine Clearance | Creatinine clearance calculated based on serum creatinine, milliliters per minute. | Up to 90 days post-transplant | |
Secondary | 24h Urine Output | 24 hour urine output post-transplantation measured in milliliters | 24 hours post-transplant | |
Secondary | Mean Number of Patients on Dialysis | Mean number of patients on dialysis at 15 to 30 days post-transplant | 15 to 30 days post-transplantation | |
Secondary | Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale) | DGF Scale: Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation >70% Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of >70% with need for dialysis Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation <70% with no need for dialysis Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of <70% with need for dialysis. |
First 7 days post-transplant |
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