An Evaluation of Patient Reported Outcomes and Clinical Outcomes

• Sponsor: Renibus Therapeutics, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06092970
• Collaborator: (none)
• Enrollment: 400
• Anticipated Duration (Months): 32.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Complications in Cardiac Surgery	Drug: RBT-1; Drug: Placebo

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Anticipated Study Start Date: Oct 23, 2023
• Anticipated Primary Completion Date: Jun 30, 2026
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Evaluation [12 Months Post-Cardiac Surgery]

   To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire

2. Evaluation [12 Months Post-Cardiac Surgery]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Renibus Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renibus Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT06092970
• Other Study ID Numbers: REN-007E
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postoperative Complications

Study Results

No Results Posted as of Oct 23, 2023