Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery

Completed · Phase 2 · Has a placebo group

Conditions studied: AKI

In brief

The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.

Key facts

Study ID

NCT04564833

Run by

Renibus Therapeutics, Inc.

People needed

152

Starts

2021-08-04

Expected to finish

2023-02-03

Last updated by the study team

2024-04-15

Who can join

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

You may qualify if…

• Male or female subjects ≥18 years of age at Screening.
• Able and willing to comply with all study procedures.
• Stable kidney function per Investigator assessment and no known episodes of AKI during the preceding 4 weeks.
• Scheduled to undergo non-emergent coronary and/or valve surgery(ies) requiring cardiopulmonary bypass, including:
• CABG alone;
• Combined CABG surgery/repair of 1 or more cardiac valves;
• Cardiac valve(s) replacement or repair alone.
• Females and males of childbearing potential must agree to use 2 forms of contraception, with at least 1 being a barrier method, or abstain from sexual activity for 30 days following study drug administration.
• Male subjects must agree not to donate or sell sperm for 30 days following study drug administration.

You may not qualify if…

• Presence of AKI (KDIGO criteria) at the time of Screening.
• Surgery to be performed without cardiopulmonary bypass.
• Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature <28°C (82.4°F).
• eGFR ≤20 mL/min/1.73m2 or need for dialysis.
• Surgery for aortic dissection or to correct a major congenital heart defect.
• Administration of iodinated contrast media within 24 hours prior to cardiac surgery or evidence of contrast-induced nephropathy prior to cardiac surgery.
• Cardiogenic shock or hemodynamic instability within the 24 hours prior to surgery and requirement for inotropes or vasopressors or other mechanical devices, such as intra-aortic balloon counter-pulsation.
• Requirement for any of the following within 7 days prior to cardiac surgery:
• Defibrillator or permanent pacemaker;
• Mechanical ventilation;
• Intra-aortic balloon counter-pulsation;
• Left ventricular assist device;
• Other forms of mechanical circulatory support.
• Known history of cancer within the past 2 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 or confirmed or treated endocarditis within 30 days prior to cardiac surgery.
• Other current active infection requiring systemic antibiotic treatment.
• Inadequate hepatic function, defined as total bilirubin or alanine aminotransferase or aspartate aminotransferase >2X the upper limit of normal at time of Screening or Child Pugh Class C liver disease or higher.
• Any congenital coagulation disorder.
• Asplenia (anatomic or functional).
• History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-1.
• Known hypersensitivity or previous anaphylaxis to SnPP or any tin-based product.
• Serum ferritin >500 ng/mL or those who have received IV iron within 28 days of Screening.
• Pregnancy or lactation.
• Treatment with an investigational drug or participation in an interventional study within 30 days prior to administration of study drug.
• In the opinion of the Investigator, any disease processes or confounding variables that would inappropriately alter the outcome of the study.

Where it is running

• Heart Center Research, LLC — Huntsville, Alabama, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• MedStar Health Research Institute, Inc. — Washington D.C., District of Columbia, United States
• University of Chicago Hospital Anesthesia and Critical Care — Chicago, Illinois, United States
• Indiana University Health Southern Indiana — Bloomington, Indiana, United States
• Lutheran Medical Group — Fort Wayne, Indiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• McLaren Greater Lansing — Lansing, Michigan, United States
• MyMichigan Medical Center — Midland, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• New York Presbyterian-Queens — Flushing, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Rochester General Hospital Center for Clinical Research — Rochester, New York, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Gold Cost University Hospital & Health Services — Southport, Queensland, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• St-John Regional Hospital — Saint John, New Brunswick, Canada
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada
• Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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