Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery (START)
- Study HIC#:2000030910
- Last Updated:01/01/0001
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.
- Age18 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Ricarda Tomlin
- Phone Number: 1-203-785-2073
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Trial Purpose and Description
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.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Inability to comply with the requirements of the study protocol.