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

Overview

About this study

The purpose of this study is to evaluate the effect of RBT-1 on preconditioning response biomarkers in subjects who are at risk for acute kidney injury (AKI) following cardiac surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Male or female subjects ≥18 years of age at Screening.

2. Able and willing to comply with all study procedures.

3. Stable kidney function per Investigator assessment and no known episodes of AKI during
the preceding 4 weeks.

4. 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.

5. 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.

6. Male subjects must agree not to donate or sell sperm for 30 days following study drug
administration.

Exclusion Criteria:

1. Presence of AKI (KDIGO criteria) at the time of Screening.

2. Surgery to be performed without cardiopulmonary bypass.

3. Surgery to be performed under conditions of circulatory arrest or hypothermia with
rectal temperature <28°C (82.4°F).

4. eGFR ≤20 mL/min/1.73m2 or need for dialysis.

5. Surgery for aortic dissection or to correct a major congenital heart defect.

6. Administration of iodinated contrast media within 24 hours prior to cardiac surgery or
evidence of contrast-induced nephropathy prior to cardiac surgery.

7. 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.

8. 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.

9. 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.

10. Known or suspected sepsis at time of Screening or confirmed or treated endocarditis
within 30 days prior to cardiac surgery.

11. Other current active infection requiring systemic antibiotic treatment.

12. 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.

13. Any congenital coagulation disorder.

14. Asplenia (anatomic or functional).

15. History of photosensitivity or active skin disease that, in the opinion of the
Investigator, could be worsened by RBT-1.

16. Known hypersensitivity or previous anaphylaxis to SnPP or any tin-based product.

17. Serum ferritin >500 ng/mL or those who have received IV iron within 28 days of
Screening.

18. Pregnancy or lactation.

19. Treatment with an investigational drug or participation in an interventional study
within 30 days prior to administration of study drug.

20. In the opinion of the Investigator, any disease processes or confounding variables
that would inappropriately alter the outcome of the study.

21. Inability to comply with the requirements of the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/31/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arman Arghami, M.D., M.P.H.

Open for enrollment

Contact information:

Mary Timmons

(507) 255-8772

Timmons.Mary@mayo.edu

More information

Publications

Publications are currently not available
.

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