An Evaluation of Patient Reported Outcomes and Clinical Outcomes

Clinical Protocol REN-007E - Extension Study: An Evaluation of Patient Reported Outcomes and Clinical Outcomes Through 12 Months Post-Cardiac Surgery in Patients Enrolled in Study REN-007

This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery:

• Patient reported outcomes (PRO), using the EQ-5D questionnaire
• Clinical outcomes

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Andre Lamy, MD
• Study Contact Backup: 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
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • 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
      • New York Presbyterian-Queens
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Research Site
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All subjects who complete the Phase 3 REN-007 study are eligible to participate in the Extension Study.

Description

Inclusion Criteria:

• Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.

Exclusion Criteria:

• Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study.
• Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RBT-1; Patients undergoing CABG, valve, or combined CABG/valve surgery	Drug: RBT-1; Intravenous administration
Placebo; Patients undergoing CABG, valve, or combined CABG/valve surgery	Drug: Placebo; Intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation	To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire	12 Months Post-Cardiac Surgery
Evaluation	The number of subjects with the following clinical outcomes will be reported Clinical Outcomes: Chronic kidney disease (CKD) - new diagnosis; Acute kidney injury (AKI) or CKD requiring dialysis; Atrial fibrillation - new-onset; Death; Myocardial infarction (MI); Non-fatal cardiac arrest; Readmission to hospital; Reoperation for coronary artery bypass graft (CABG) and/or valve dysfunction; Stroke	12 Months Post-Cardiac Surgery

Collaborators and Investigators

• Sponsor: Renibus Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 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

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: REN-007E

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