Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
NCT ID: NCT02771509
Last Updated: 2021-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
275 participants
INTERVENTIONAL
2017-02-24
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
ANG-3777
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
Normal Saline
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.
Placebo
Normal saline
Interventions
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ANG-3777
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
Placebo
Normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.
3. Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure involving CPB. Eligible procedures include:
1. Coronary artery bypass graft (CABG) alone
2. Aortic valve replacement or repair alone, with or without aortic root repair
3. Mitral, tricuspid, or pulmonic valve replacement or repair alone
4. Combined replacement of several cardiac valves
5. CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
6. CABG with combined cardiac valve replacement or repair.
4. Patient must have the following risk factor(s) for AKI prior to surgery:
1. Estimated glomerular filtration rate (eGFR) of ≥ 20 and \< 30 ml/min/1.73m2, or
2. eGFR ≥ 30 and \< 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age ≥ 75 years), or
3. 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.
5. 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.
6. Patient's body mass index (BMI) \< 40 at Screening.
Exclusion Criteria
2. 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.
3. Currently active infection requiring antibiotic treatment.
4. 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.
5. Administration of iodinated contrast material within 24 hours prior to cardiac surgery.
6. Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.
18 Years
ALL
No
Sponsors
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Everest Clinical Research
UNKNOWN
CTI Clinical Trial and Consulting Services
OTHER
Clinical Accelerator
INDUSTRY
Angion Biomedica Corp
INDUSTRY
Responsible Party
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Principal Investigators
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John Neylan, MD
Role: STUDY_DIRECTOR
Angion Biomedica
Locations
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University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
California Institute of Renal Reseach
San Diego, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
UF Health at Unviersity of Florida
Gainesville, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Indiana Ohio Heart
Fort Wayne, Indiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
MidMichigan Medical Center Midland
Midland, Michigan, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
Bryan Heart
Lincoln, Nebraska, United States
Columbia University Medical Center
New York, New York, 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
Cleveland Clinic Fairview
Cleveland, Ohio, United States
Ohio State Wexner Medical Center
Columbus, Ohio, United States
Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Faculdade de Medicina da UNESP Campus de Botucatu
Botucatu, , Brazil
Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC - FUC)
Porto Alegre, , Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)
Ribeirão Preto, , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, , Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor - HCFMUSP)
São Paulo, , Brazil
St. John Regional Hospital
Saint John, New Brunswick, Canada
London Health Sciences Center
London, Ontario, Canada
Saint Michael's Hospital
Toronto, Ontario, Canada
CHUM - Hôtel Dieu
Montreal, Quebec, Canada
MUHC - Royal Victoria Hospital
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, , Canada
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
New Hospitals LTD
Tbilisi, , Georgia
Bokhua Memorial Cardiovascular Center
Tbilisi, , Georgia
Jerarsi JSC
Tbilisi, , Georgia
Tbilisi Heart Center
Tbilisi, , Georgia
Acad. G. Chapidze Emergency Cardiology Center
Tbilisi, , Georgia
Countries
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Other Identifiers
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002-15
Identifier Type: -
Identifier Source: org_study_id
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