Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
NCT ID: NCT04564833
Last Updated: 2024-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2021-08-04
2023-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Low Dose RBT-1
Single IV infusion prior to cardiac surgery
Low Dose RBT-1
intravenous administration
High Dose RBT-1
Single IV infusion prior to cardiac surgery
High Dose RBT-1
intravenous administration
Placebo
Single IV infusion prior to cardiac surgery
Placebo
intravenous administration
Interventions
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Low Dose RBT-1
intravenous administration
High Dose RBT-1
intravenous administration
Placebo
intravenous administration
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Renibus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Lamy A, Chertow GM, Jessen M, Collar A, Brown CD, Mack CA, Marzouk M, Scavo V, Washburn TB, Savage D, Smith J, Bennetts J, Assi R, Shults C, Arghami A, Butler J, Devereaux PJ, Zager R, Wang C, Snapinn S, Browne A, Rodriguez J, Ruiz S, Singh B; of START Investigators. Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. EClinicalMedicine. 2024 Jan 8;68:102364. doi: 10.1016/j.eclinm.2023.102364. eCollection 2024 Feb.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial
Other Identifiers
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REN-004
Identifier Type: -
Identifier Source: org_study_id
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