Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

NCT06021457 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: REN-007
• Study Type: interventional
• Target: 454
• Locations: 2 countries
• Sites: 41

Brief Summary

The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.

Conditions

Post-Operative Complications in Cardiac Surgery

Keywords

Cardiac Surgery; CABG; Valve; Cardiopulmonary Bypass; Preconditioning

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days).

  The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.

  Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable

Secondary Outcomes (3)

• Composite of the Number of Post-operative Complications

  Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable

• ICU Days

  Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)

• 30-day Cardiopulmonary Readmission Rates

  Within 30-days post-discharge

Study Arms (2)

RBT-1

EXPERIMENTAL

Single IV infusion prior to cardiac surgery

Drug: RBT-1

Placebo

PLACEBO COMPARATOR

Single IV infusion prior to cardiac surgery

Drug: Placebo

Interventions

RBT-1 DRUG

Intravenous administration

RBT-1

Placebo DRUG

Intravenous administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥18 years of age at Screening.
• 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.
• 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.
• 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.
• Willingness to comply with all study-related procedures and assessments.

You may not qualify if:

• Surgery planned to occur \<24 hours from the start of study drug infusion.
• 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.
• Surgery to be performed without CPB.
• Chronic kidney disease (CKD) requiring dialysis.
• Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low.
• Cardiogenic shock or immediate requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP).
• 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.
• Known or suspected sepsis at time of Screening.
• Asplenia (anatomic or functional).
• History of hemochromatosis, iron overload, or porphyria.
• Known hypersensitivity or previous anaphylaxis to SnPP or FeS.
• Female subject who is pregnant or breastfeeding.
• Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion or throughout participation in REN-007.
• In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.

Sponsors & Collaborators

• Renibus Therapeutics, Inc.: lead

Study Sites (41)

Research Site

Huntsville, Alabama, 35801, United States

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La Jolla, California, 92037, United States

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San Francisco, California, 94107, United States

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Stanford, California, 94305, United States

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Washington D.C., District of Columbia, 20011, United States

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Atlantis, Florida, 33462, United States

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Gainesville, Florida, 32608, United States

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Athens, Georgia, 30606, United States

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Atlanta, Georgia, 30342, United States

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Fort Wayne, Indiana, 46804, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46237, United States

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Kansas City, Kansas, 66160, United States

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Boston, Massachusetts, 02115, United States

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Ann Arbor, Michigan, 48109, United States

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Lansing, Michigan, 48879, United States

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Midland, Michigan, 48670, United States

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Royal Oak, Michigan, 48703, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63310, United States

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Flushing, New York, 11355, United States

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Raleigh, North Carolina, 27610, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44106, United States

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Toledo, Ohio, 43606, United States

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Charleston, South Carolina, 29466, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Charlottesville, Virginia, 22903, United States

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Kelowna, British Columbia, V1Y 0C5, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H2X 0C1, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Québec, Quebec, G1V 4G5, Canada

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Study Officials

• Andre Lamy, MD

  World Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 to RBT-1 or placebo

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 1, 2023
• Study Start: October 17, 2023
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10); US (31)