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| Name | Class |
|---|---|
| Everest Clinical Research | UNKNOWN |
| CTI Clinical Trial and Consulting Services | OTHER |
| Clinical Accelerator | INDUSTRY |
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The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANG-3777 | Active Comparator | Study drug will be administered for a total of 4 daily intravenous (IV) infusions. The first post-operative dose MUST be started within 4 hours of completing CPB. The second dose will be administered 24 ± 2 hours after completing CPB, and the third and fourth doses will be administered 24 ± 2 hours after each previous dose. Duration of administration is 30 minutes. |
|
| Normal Saline | Placebo Comparator | The placebo will be administered for a total of 4 daily intravenous (IV) infusions. The first post-operative dose MUST be started within 4 hours of completing CPB. The second dose will be administered 24 ± 2 hours after completing CPB, and the third and fourth doses will be administered 24 ± 2 hours after each previous dose. Duration of administration is 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANG-3777 | Drug | 6 mg/mL BB3, IV, 4 days in a row, first dose must be within 4 hours after surgery, the next three doses will be approx. 24 hours after the last dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean AUC of the percent increase in serum creatinine above baseline | starting from 24 hr after the end of CPB through Day 6 |
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Inclusion Criteria:
Patient is either male or female ≥ 18 years.
Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.
Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure involving CPB. Eligible procedures include:
Patient must have the following risk factor(s) for AKI prior to surgery:
eGFR will be calculated using the abbreviated MDRD equation (MDRD-4, often referred to as the Levey equation): eGFR = 186.3 x sCr-1.154 x Age-0.203 x [0.742 if Female] x [1.212 if Black]
Additional Risk Factors:
Patient must have presented for surgery without prior evidence of active renal injury defined as no acute rise in sCr > 0.3 mg/dL or no 50% increase in sCr between the time of Screening and pre-surgery.
Patient's body mass index (BMI) < 40 at Screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Neylan, MD | Angion Biomedica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39603491 | Derived | Ayad SS, Beaver T, Corteville D, Swaminathan M, Pearl RG, Aslam S, Csomor PA, Alperovich G, Neylan J. Development of and recovery from acute kidney injury after cardiac surgery: Randomized phase 2 trial of the hepatocyte growth factor mimetic ANG-3777. J Thorac Cardiovasc Surg. 2025 Oct;170(4):1125-1132.e2. doi: 10.1016/j.jtcvs.2024.11.024. Epub 2024 Nov 26. |
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|
| Placebo | Drug | Normal saline |
|
|
| Los Angeles |
| California |
| 90048 |
| United States |
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| California Institute of Renal Reseach | San Diego | California | 92123 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32207 | United States |
| UF Health at Unviersity of Florida | Gainesville | Florida | 32610 | United States |
| River City Clinical Research | Jacksonville | Florida | 32207 | United States |
| Indiana Ohio Heart | Fort Wayne | Indiana | 46804 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Suburban Hospital | Bethesda | Maryland | 20814 | United States |
| MidMichigan Medical Center Midland | Midland | Michigan | 49770 | United States |
| Cardiac & Vascular Research Center of Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| TriHealth | Cincinnati | Ohio | 45220 | United States |
| Cleveland Clinic Fairview | Cleveland | Ohio | 44111 | United States |
| Ohio State Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center | Dallas | Texas | 75226 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| Faculdade de Medicina da UNESP Campus de Botucatu | Botucatu | 18618-686 | Brazil |
| Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC - FUC) | Porto Alegre | 90040-371 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP) | Ribeirão Preto | 14048-900 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor - HCFMUSP) | São Paulo | 05403-000 | Brazil |
| St. John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| London Health Sciences Center | London | Ontario | N6A 5A5 | Canada |
| Saint Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| CHUM - Hôtel Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| MUHC - Royal Victoria Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | G1V 4G5 | Canada |
| Israeli-Georgian Medical Research Clinic Helsicore | Tbilisi | 0112 | Georgia |
| New Hospitals LTD | Tbilisi | 0114 | Georgia |
| Bokhua Memorial Cardiovascular Center | Tbilisi | 0159 | Georgia |
| Jerarsi JSC | Tbilisi | 0167 | Georgia |
| Tbilisi Heart Center | Tbilisi | 0186 | Georgia |
| Acad. G. Chapidze Emergency Cardiology Center | Tbilisi | 0519 | Georgia |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| 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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