Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
- Registration Number
- NCT02771509
- Lead Sponsor
- Angion Biomedica Corp
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 275
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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:
- Coronary artery bypass graft (CABG) alone
- Aortic valve replacement or repair alone, with or without aortic root repair
- Mitral, tricuspid, or pulmonic valve replacement or repair alone
- Combined replacement of several cardiac valves
- CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- CABG with combined cardiac valve replacement or repair.
-
Patient must have the following risk factor(s) for AKI prior to surgery:
- Estimated glomerular filtration rate (eGFR) of ≥ 20 and < 30 ml/min/1.73m2, or
- eGFR ≥ 30 and < 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age ≥ 75 years), or
- eGFR ≥ 60 ml/min/1.73m2 and TWO of the following Additional Risk Factors
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:
- Combined valve and coronary surgery
- Previous cardiac surgery with sternotomy
- Left ventricular ejection fraction (LVEF) < 35% by invasive or noninvasive diagnostic cardiac imaging within 90 days prior to surgery
- Diabetes mellitus requiring insulin treatment
- Non-insulin-requiring diabetes with documented presence of at least moderate (+2 or > 100 mg/dL) proteinuria on urine analysis (medical history or dipstick)
- Documented NYHA Class III or IV within 1 year prior to index surgery
- Age ≥ 75 years can be considered an Additional Risk Factor only for patients with eGFR ≥ 60 ml/min/1.73m2.
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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.
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Patient's body mass index (BMI) < 40 at Screening.
- Patient has eGFR < 20 mL/min/1.73 m2 within 48 hours pre-surgery as measured by MDRD 4.
- Patient has ongoing sepsis or partially treated infection. Sepsis is defined as the presence of a confirmed pathogen, along with fever or hypoperfusion (i.e., acidosis and new onset elevation of liver function tests) or hypotension requiring pressor use prior to surgery.
- Currently active infection requiring antibiotic treatment.
- Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- Administration of iodinated contrast material within 24 hours prior to cardiac surgery.
- Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ANG-3777 ANG-3777 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 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.
- Primary Outcome Measures
Name Time Method The mean AUC of the percent increase in serum creatinine above baseline starting from 24 hr after the end of CPB through Day 6
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Tbilisi Heart Center
🇬🇪Tbilisi, Georgia
Acad. G. Chapidze Emergency Cardiology Center
🇬🇪Tbilisi, Georgia
Bryan Heart
🇺🇸Lincoln, Nebraska, United States
Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center
🇺🇸Dallas, Texas, United States
St. John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Bokhua Memorial Cardiovascular Center
🇬🇪Tbilisi, Georgia
University of Southern California
🇺🇸Los Angeles, California, United States
Indiana Ohio Heart
🇺🇸Fort Wayne, Indiana, United States
MidMichigan Medical Center Midland
🇺🇸Midland, Michigan, United States
Cardiac & Vascular Research Center of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cleveland Clinic Fairview
🇺🇸Cleveland, Ohio, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Saint Michael's Hospital
🇨🇦Toronto, Ontario, Canada
CHUM - Hôtel Dieu
🇨🇦Montréal, Quebec, Canada
Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC - FUC)
🇧🇷Porto Alegre, Brazil
Faculdade de Medicina da UNESP Campus de Botucatu
🇧🇷Botucatu, Brazil
New Hospitals LTD
🇬🇪Tbilisi, Georgia
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José Do Rio Preto, Brazil
London Health Sciences Center
🇨🇦London, Ontario, Canada
MUHC - Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
Jerarsi JSC
🇬🇪Tbilisi, Georgia
UF Health at Unviersity of Florida
🇺🇸Gainesville, Florida, United States
River City Clinical Research
🇺🇸Jacksonville, Florida, United States
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor - HCFMUSP)
🇧🇷São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)
🇧🇷Ribeirão Preto, Brazil
Israeli-Georgian Medical Research Clinic Helsicore
🇬🇪Tbilisi, Georgia
Institut Universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦Québec, Canada
Ohio State Wexner Medical Center
🇺🇸Columbus, Ohio, United States
California Institute of Renal Reseach
🇺🇸San Diego, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Duke University
🇺🇸Durham, North Carolina, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
TriHealth
🇺🇸Cincinnati, Ohio, United States