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

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: Recruiting
• Conditions: Post-Operative Complications in Cardiac Surgery
• Intervention / Treatment: Drug: Placebo; Drug: RBT-1

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jennifer Paleveda; Phone Number: 813-760-3975; Email: jpaleveda@renibus.com

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Recruiting
      • Research Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20011
      • Recruiting
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Research Site
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Research Site
  • Michigan
    • Lansing, Michigan, United States, 48879
      • Recruiting
      • Research Site
    • Midland, Michigan, United States, 48670
      • Recruiting
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Research Site
  • New York
    • Flushing, New York, United States, 11355
      • Recruiting
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • Research Site
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Research Site
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • Research Site

Participation Criteria

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 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.
14. In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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, days in ICU, and 30-day cardiopulmonary readmission	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	Days in ICU	Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
30-day Cardiopulmonary Readmission Rates	Readmissions due to cardiopulmonary reasons	Within 30-days post-discharge
Composite of the Number of Post-operative Complications	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

• Sponsor: Renibus Therapeutics, Inc.
• Investigators: Principal Investigator: Andre Lamy, MD, World Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 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 (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: CABG; Cardiac Surgery; Cardiopulmonary Bypass; Preconditioning; Valve
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• 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