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| Name | Class |
|---|---|
| CTI Clinical Trial and Consulting Services | OTHER |
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The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BB3 | Active Comparator | Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row |
|
| Normal Saline | Placebo Comparator | Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANG-3777 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The severity of DGF | The primary endpoint is renal function assessed by eGFR (using the CKD-EPI equation based on serum creatinine), with a primary analysis time point consisting of eGFR at month 12. | Day 360 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| John Neylan, MD | Angion Biomedica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | United States | ||
| Keck Hospital of USC |
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| Other |
|
|
| Los Angeles |
| California |
| 90033 |
| United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| California Pacific Medical Center (Sutter) | San Francisco | California | 94115 | United States |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States |
| University of Colorado Hospital Anschuts Medical Campus | Aurora | Colorado | 80045 | United States |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Kansas University | Lawrence | Kansas | 66045 | United States |
| University of Louisville | Louisville | Kentucky | 40292 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55454 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Montefiore Medical Center BRANY | The Bronx | New York | 10467 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| Virginia Commonwealth University (VCU) Medical Center of Virginia | Richmond | Virginia | 23298 | United States |
| University of Washinton Medical Center | Seattle | Washington | 98195 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000711731 | terevalefim |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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