Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

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).

Key facts

Study ID

NCT02771509

Run by

Angion Biomedica Corp

People needed

275

Starts

2017-02-24

Expected to finish

2021-08-01

Last updated by the study team

2021-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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