A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

The purpose of this study is to determine whether THR-184 when administered around the time of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the development of acute kidney injury.

Key facts

Study ID

NCT01830920

Run by

Thrasos Innovation, Inc.

People needed

452

Starts

2013-05-01

Expected to finish

2015-09-01

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female and >18 years of age.
• Scheduled for a non-emergent coronary and/or valve surgery procedure requiring CPB, to 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;
• simultaneous replacement of several cardiac valves;
• CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair;
• CABG with combined cardiac valve replacement or repair.
• Have the following risk factors for CSA-AKI:
• eGFR ≥ 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
• Additional Risk Factors:
• Age ≥ 75 years;
• Combined valve \& coronary surgery;
• Previous cardiac surgery with sternotomy;
• Documented NYHA Class III or IV within 1 year prior to surgery;
• Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive diagnostic cardiac imaging - echocardiography, nuclear imaging, computed tomography, magnetic resonance imaging or angiography performed within 90 days prior to surgery. (If LVEF ≤ 35% by any invasive or noninvasive imaging procedure, patient meets the risk factor.)
• Insulin-requiring diabetes;
• Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (medical history or dipstick);
• Preoperative anemia (hemoglobin <11g/dl for men and women).

You may not qualify if…

• If any of the following criteria apply prior to surgery, the patient will be excluded from the study:
• Age > 85 years;
• Weight >174 kg or 383 lbs;
• The presence of AKI (KDIGO criteria) at the time of screening ;
• Surgery to be performed without CPB;
• Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature < 28°Celsius (82.4° Fahrenheit);
• eGFR (MDRD) <20 ml/min/1.73m2;
• Surgery for aortic dissection;
• Surgery to correct a major congenital heart defect (e.g., Tetralogy of Fallot, transposition of the great vessels, single ventricle, Ebsteins anomaly. Bicuspid aortic valve is not to be considered a congenital heart defect.);
• Prior organ transplantation;
• Dialysis-dependence;
• Administration of iodinated contrast media within 24 hours prior to cardiac surgery;
• If received contrast media prior to 24 hours and have AKI as defined by KDIGO criteria;
• Cardiogenic shock or haemodynamic instability within the 24 hours prior to surgery, including the anesthesia induction period; as defined by a systolic BP <80 mm Hg and pulse >120 beats per minute (bpm) and requirement for inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP);
• Requirement for any of the following within seven (7) days prior to cardiac surgery:
• defibrillator or permanent pacemaker,
• mechanical ventilation,
• intra-aortic balloon counter-pulsation (IABP),
• left ventricular assist device (LVAD),
• other forms of mechanical circulatory support (MCS);
• Cardiopulmonary resuscitation within 14 days prior to cardiac surgery;
• Known history of cancer within the past 5 years, except for carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin;
• Known or suspected sepsis at time of screening;
• Known or suspected glomerulonephritis or interstitial nephritis at time of screening;
• Confirmed or treated endocarditis within previous 30 days prior to cardiac surgery;

Where it is running

• University of Alabama-Birmingham — Birmingham, Alabama, United States
• University of Southern California — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Harbor - University of California Los Angeles Medical Center — Torrance, California, United States
• Danbury Hospital — Danbury, Connecticut, United States
• River City Clinical Research — Jacksonville, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Indiana Ohio Heart — Fort Wayne, Indiana, United States
• Indiana Heart-St. Vincent Medical Group — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• John Hopkins University — Baltimore, Maryland, United States
• Suburban Hospital — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Cardiac and Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States
• Covenant Medical Center — Saginaw, Michigan, United States
• Washington University — St Louis, Missouri, United States
• St. Joseph's Regional Medical Center — Paterson, New Jersey, United States
• St. Peter's Hospital — Albany, New York, United States
• Columbia University — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Durham VA Medical Center — Durham, North Carolina, United States
• Lindner Research Center-Christ Hospital — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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