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The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient. This research study will compare Berinert to placebo. The placebo looks exactly like Berinert but does not contain any active drug. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Neither you or the study doctor can choose or know which group is assigned.
The primary objective is to test whether intrarenal artery C1 esterase inhibitor (C1INH) injection into the donor kidney prior to transplantation improves kidney function in recipients of high risk, deceased donor kidney transplants as measured by 12-month Estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berinert | Experimental |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berinert | Biological | Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between study arms in renal function | Measured as Estimated Glomerular Filtration Rate Chronic Kidney Disease Epidemiology Collaboration (eGFRCKD-EPI) in ml/min/1.73m^2 | At 12-months post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between the treated and control group of the full iBox score | The iBox scoring system is a composite biomarker panel. The full iBox scoring system consists of 4 elements all obtained 1-year post-transplant: a) eGFR (MDRD), b) DSA, c) urinary protein/creatine ratio, and d) histological abnormalities on a surveillance biopsy. | At 12-months post-transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Heeger, MD | Cedars-Sinai Medical Center | Study Chair |
| Sindhu Chandran, MBBS, MD | Cedars-Sinai Medical Center | Study Chair |
| Stanley Jordan, MD | Cedars-Sinai Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
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This study is a double-blind, placebo-controlled study.
| Placebo for Berinert | Other | Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft |
|
| Incidence of biopsy proven acute rejection (BPAR) | At 12-months post-transplantation |
| Incidence of proteinuria | Measured as spot urine protein/creatinine >1 g/g | At 12-months post-transplantation |
| Incidence of de novo donor specific anti-Human Leukocyte Antigen (HLA) antibody (DSA) | Defined as the incidence of de novo DSA on standard of care or protocol directed blood draws up to and including the 12-month protocol blood draw. | At 12-months post-transplantation |
| Incidence of Grade 3 or higher infections | At 12-months post-transplantation |
| Incidence of Grade 3 or higher intraoperative or postoperative hemorrhage | Within 4 weeks after transplantation |
| Incidence of thrombotic or thromboembolic events | Excluding superficial thrombophlebitis, catheter-related thrombosis and dialysis access thrombosis | Within 4 weeks after transplantation |
| Incidence of T cell mediated rejection (TCMR) that is steroid resistant | At 12-months post-transplantation |
| Incidence of TCMR that is BANFF grade 2 or higher | At 12-months post-transplantation |
| Incidence of antibody mediated rejection (ABMR) | At 12-months post-transplantation |
| Incidence of death | At 12-months post-transplantation |
| Incidence of Graft loss (including primary non function) | At 12-months post-transplantation |
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Kansas University Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467-2401 | United States |
|
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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| ID | Term |
|---|---|
| D050718 | Complement C1 Inhibitor Protein |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D003174 | Complement C1 Inactivator Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003169 | Complement Inactivator Proteins |
| D003165 | Complement System Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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