Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac… (NCT04564833) | Clinical Trial Compass
CompletedPhase 2
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
United States152 participantsStarted 2021-08-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
✕. 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: