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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04564833
Other study ID # REN-004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 4, 2021
Est. completion date February 3, 2023

Study information

Verified date April 2024
Source Renibus Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date February 3, 2023
Est. primary completion date November 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Low Dose RBT-1
intravenous administration
High Dose RBT-1
intravenous administration
Placebo
intravenous administration

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Renibus Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

References & Publications (1)

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 In — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers Composite of the geometric mean of the ratios of the maximum PreOp value over Baseline for plasma heme oxygenase-1 (HO-1), ferritin, and interleukin-10 (IL-10) Baseline through Pre-Surgery
Secondary Change in Renal Tubular Injury Biomarkers Geometric mean of the ratios of the maximum PostOp value over Baseline for urine KIM-1, NGAL, and cystatin C. Baseline through Day 3 post-cardiac surgery
Secondary Number of Subjects With Reduction in Urine Output Documented AE of sustained reduction in urine output, oliguria, or anuria post-cardiac surgery through Day 5 Baseline through post-cardiac surgery through Day 5
Secondary Number of Subjects With Acute Kidney Injury (AKI) AKI is defined using the KDIGO criteria (ie, an absolute increase in serum creatinine of =1.5 × Baseline; or documented AE of sustained reduction in urine output, oliguria, or anuria; or initiation of dialysis). Baseline through Day 5 post-cardiac surgery
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