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

July 31, 2025 updated by: Renibus Therapeutics, Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

454

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 0C5
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Research Site
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Research Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Research Site
    • Quebec
      • Montréal, Quebec, Canada, H1T 1C8
        • Research Site
      • Montréal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montréal, Quebec, Canada, H2X 0C1
        • Research Site
      • Montréal, Quebec, Canada, H4J 1C5
        • Research Site
      • Québec, Quebec, Canada, G1V 4G5
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • California
      • La Jolla, California, United States, 92037
        • Research Site
      • San Francisco, California, United States, 94107
        • Research Site
      • Stanford, California, United States, 94305
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Research Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • Research Site
      • Gainesville, Florida, United States, 32608
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Research Site
      • Indianapolis, Indiana, United States, 46237
        • Research Site
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Lansing, Michigan, United States, 48879
        • Research Site
      • Midland, Michigan, United States, 48670
        • Research Site
      • Royal Oak, Michigan, United States, 48703
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63310
        • Research Site
    • New York
      • Flushing, New York, United States, 11355
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Research Site
      • Winston-Salem, North Carolina, United States, 27157
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Research Site
      • Toledo, Ohio, United States, 43606
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29466
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, ≥18 years of age at Screening.
  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:

  1. Surgery planned to occur <24 hours from the start of study drug infusion.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Single IV infusion prior to cardiac surgery
Drug: Placebo
Intravenous administration
Experimental: RBT-1
Single IV infusion prior to cardiac surgery
Drug: RBT-1
Intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days).
Time Frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Days
Time Frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
Days in ICU
Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
30-day Cardiopulmonary Readmission Rates
Time Frame: Within 30-days post-discharge
Readmissions due to cardiopulmonary reasons
Within 30-days post-discharge
Composite of the Number of Post-operative Complications
Time Frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable

The number of the following post-operative complications per patient will be assessed:

  • Death
  • AKI requiring dialysis
  • >3 days in ICU
  • >24 hours on ventilator
  • 30-day cardiopulmonary readmission
  • Need for blood transfusion during index hospitalization
  • New-onset atrial fibrillation during index hospitalization
Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renibus Therapeutics, Inc.

Investigators

  • Principal Investigator: Andre Lamy, MD, World Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Actual)

June 17, 2025

Study Completion (Actual)

June 17, 2025

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REN-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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