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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564833
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Renibus Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
AKI Drug: Low Dose RBT-1 Drug: High Dose RBT-1 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized 1:1:1 to low dose RBT-1, high dose RBT-1, and placebo
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery (The START Study)
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : November 30, 2022

Arm Intervention/treatment
Experimental: Low Dose RBT-1
Single IV infusion prior to cardiac surgery
Drug: Low Dose RBT-1
intravenous administration

Experimental: High Dose RBT-1
Single IV infusion prior to cardiac surgery
Drug: High Dose RBT-1
intravenous administration

Placebo Comparator: Placebo
Single IV infusion prior to cardiac surgery
Drug: Placebo
intravenous administration




Primary Outcome Measures :
  1. Evaluate the efficacy of RBT-1 in generating a preconditioning response as measured by a composite of biomarkers [ Time Frame: Baseline through Day 3 post-dose ]
    Plasma heme oxygenase-1 (HO-1), ferritin, and interleukin-10 (IL-10)


Secondary Outcome Measures :
  1. Change in renal tubular injury biomarkers [ Time Frame: Baseline through Day 3 post-cardiac surgery ]
    KIM-1, NGAL, cystatin C

  2. Reduction in urine output [ Time Frame: Baseline through Day 3 post-cardiac surgery ]
    Documented oliguria of <0.5 mL/kg/hour for more than 6 hours post-cardiac surgery

  3. Incidence of acute kidney injury (AKI) [ Time Frame: Baseline through Day 5 post-cardiac surgery ]
    AKI is defined using the KDIGO criteria (ie, an absolute increase in serum creatinine by 0.5 mg/dL, which is present over 2 laboratory measurements at least 12 hours apart; or an increase in serum creatinine ≥1.5 × Baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564833


Contacts
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Contact: Ayla Rasmussen 443-569-9228 arasmussen@renibus.com

Locations
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Sponsors and Collaborators
Renibus Therapeutics, Inc.
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Responsible Party: Renibus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04564833    
Other Study ID Numbers: REN-004
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No