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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04564833




Registration number
NCT04564833
Ethics application status
Date submitted
21/09/2020
Date registered
25/09/2020

Titles & IDs
Public title
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
Scientific 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)
Secondary ID [1] 0 0
REN-004
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AKI 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Low Dose RBT-1
Treatment: Drugs - High Dose RBT-1
Treatment: Drugs - Placebo

Experimental: Low Dose RBT-1 - Single IV infusion prior to cardiac surgery

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

Placebo comparator: Placebo - Single IV infusion prior to cardiac surgery


Treatment: Drugs: Low Dose RBT-1
intravenous administration

Treatment: Drugs: High Dose RBT-1
intravenous administration

Treatment: Drugs: Placebo
intravenous administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
Timepoint [1] 0 0
Baseline through Pre-Surgery
Secondary outcome [1] 0 0
Change in Renal Tubular Injury Biomarkers
Timepoint [1] 0 0
Baseline through Day 3 post-cardiac surgery
Secondary outcome [2] 0 0
Number of Subjects With Reduction in Urine Output
Timepoint [2] 0 0
Baseline through post-cardiac surgery through Day 5
Secondary outcome [3] 0 0
Number of Subjects With Acute Kidney Injury (AKI)
Timepoint [3] 0 0
Baseline through Day 5 post-cardiac surgery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/02/2023
Sample size
Target
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Gold Cost University Hospital & Health Services - Southport
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
New Brunswick
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Renibus Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Lamy A, Chertow GM, Jessen M, Collar A, Brown CD, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04564833