Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
NCT ID: NCT06021457
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
454 participants
INTERVENTIONAL
2023-10-17
2025-06-17
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
QUADRUPLE
Study Groups
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RBT-1
Single IV infusion prior to cardiac surgery
RBT-1
Intravenous administration
Placebo
Single IV infusion prior to cardiac surgery
Placebo
Intravenous administration
Interventions
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RBT-1
Intravenous administration
Placebo
Intravenous administration
Eligibility Criteria
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Inclusion Criteria
2. Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery.
3. If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation.
4. If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner for the duration of their study participation, unless the subject has had a vasectomy ≥6 months prior to infusion with study drug.
5. Willingness to comply with all study-related procedures and assessments.
Exclusion Criteria
2. Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the Investigator at the time of Screening.
3. Surgery to be performed without CPB.
4. Chronic kidney disease (CKD) requiring dialysis.
5. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low.
6. Cardiogenic shock or immediate requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP).
7. Known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma cancer of the skin.
8. Known or suspected sepsis at time of Screening.
9. Asplenia (anatomic or functional).
10. History of hemochromatosis, iron overload, or porphyria.
11. Known hypersensitivity or previous anaphylaxis to SnPP or FeS.
12. Female subject who is pregnant or breastfeeding.
13. Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion or throughout participation in REN-007.
14. In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.
18 Years
ALL
No
Sponsors
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Renibus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andre Lamy, MD
Role: PRINCIPAL_INVESTIGATOR
World Health Research Institute
Locations
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Research Site
Huntsville, Alabama, United States
Research Site
La Jolla, California, United States
Research Site
San Francisco, California, United States
Research Site
Stanford, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Atlantis, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Athens, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Kansas City, Kansas, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Lansing, Michigan, United States
Research Site
Midland, Michigan, United States
Research Site
Royal Oak, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Flushing, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Charleston, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Kelowna, British Columbia, Canada
Research Site
Saint John, New Brunswick, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Countries
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Other Identifiers
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REN-007
Identifier Type: -
Identifier Source: org_study_id
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