An Evaluation of Patient Reported Outcomes and Clinical Outcomes

August 11, 2026 updated by: Renibus Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
353

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Andre Lamy, MD

Study Contact Backup

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
      • St. 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
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada, H2X 0C1
        • Research Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Research Site
      • Québec, Quebec, Canada, G1V 4G5
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • California
      • San Francisco, California, United States, 94107
        • Research Site
      • Stanford, California, United States, 94305
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • 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, 48073
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63310
        • Research Site
    • New York
      • Flushing, New York, United States, 11355
        • New York Presbyterian-Queens
    • 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
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation
Time Frame: 12 Months Post-Cardiac Surgery
To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire
12 Months Post-Cardiac Surgery
Evaluation
Time Frame: 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
12 Months Post-Cardiac Surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Renibus Therapeutics, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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