An Evaluation of Patient Reported Outcomes and Clinical Outcomes

NCT ID: NCT06092970

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

379 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-16

Study Completion Date

2026-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Post-Operative Complications in Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RBT-1

Patients undergoing CABG, valve, or combined CABG/valve surgery

RBT-1

Intervention Type DRUG

Intravenous administration

Placebo

Patients undergoing CABG, valve, or combined CABG/valve surgery

Placebo

Intervention Type DRUG

Intravenous administration

Interventions

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RBT-1

Intravenous administration

Intervention Type DRUG

Placebo

Intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renibus Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Huntsville, Alabama, United States

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San Francisco, California, United States

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Stanford, California, United States

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Washington D.C., District of Columbia, United States

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Atlantis, Florida, United States

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Gainesville, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Lansing, Michigan, United States

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Midland, Michigan, United States

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Royal Oak, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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New York Presbyterian-Queens

Flushing, New York, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Kelowna, British Columbia, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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REN-007E

Identifier Type: -

Identifier Source: org_study_id

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