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TerminatedNCT06092970Updated Aug 13, 2026

An Evaluation of Patient Reported Outcomes and Clinical Outcomes

An observational study in Post-Operative Complications in Cardiac Surgery, sponsored by Renibus Therapeutics, Inc.. Terminated at 39 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Renibus Therapeutics, Inc. · Observational

Why this study was terminated
REN-007 main study failed to meet primary objectives, therefore this extension study was terminated.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
353
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Post-Operative Complications in Cardiac Surgery
03

In context

Lead sponsor

Renibus Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
353 participants (actual)
Patient registry
No

Groups and cohorts

  • RBT-1

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

    Drug: RBT-1

  • Placebo

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

    Drug: Placebo

Interventions

  • DrugRBT-1

    Intravenous administration

  • DrugPlacebo

    Intravenous administration

06

What researchers measure

Primary outcomes

  1. Evaluation

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

    Time frame: 12 Months Post-Cardiac Surgery

  2. 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

    Time frame: 12 Months Post-Cardiac Surgery

07

Study locations

39 sites
  • Research Site
    Huntsville, Alabama 35801, United States
  • Research Site
    San Francisco, California 94107, United States
  • Research Site
    Stanford, California 94305, United States
  • Research Site
    Washington D.C., District of Columbia 20010, United States
  • Research Site
    Atlantis, Florida 33462, United States
  • Research Site
    Gainesville, Florida 32608, United States
  • Research Site
    Athens, Georgia 30606, United States
  • Research Site
    Atlanta, Georgia 30342, United States
  • Research Site
    Fort Wayne, Indiana 46804, United States
  • Research Site
    Indianapolis, Indiana 46202, United States
  • Research Site
    Indianapolis, Indiana 46237, United States
  • Research Site
    Kansas City, Kansas 66160, United States
  • Research Site
    Boston, Massachusetts 02115, United States
  • Research Site
    Ann Arbor, Michigan 48109, United States
  • Research Site
    Lansing, Michigan 48879, United States
  • Research Site
    Midland, Michigan 48670, United States
  • Research Site
    Royal Oak, Michigan 48073, United States
  • Research Site
    Rochester, Minnesota 55905, United States
  • Research Site
    St Louis, Missouri 63310, United States
  • New York Presbyterian-Queens
    Flushing, New York 11355, United States
  • Research Site
    Raleigh, North Carolina 27610, United States
  • Research Site
    Winston-Salem, North Carolina 27157, United States
  • Research Site
    Cleveland, Ohio 44106, United States
  • Research Site
    Toledo, Ohio 43606, United States
  • Research Site
    Nashville, Tennessee 37203, United States
  • Research Site
    Dallas, Texas 75390, United States
  • Research Site
    Houston, Texas 77030, United States
  • Research Site
    San Antonio, Texas 78229, United States
  • Research Site
    Charlottesville, Virginia 22903, United States
  • Research Site
    Kelowna, British Columbia V1Y 0C5, Canada
  • Research Site
    Saint John, New Brunswick E2L 4L2, Canada
  • Research Site
    St. John's, Newfoundland and Labrador A1B 3V6, Canada
  • Research Site
    Hamilton, Ontario L8L 2X2, Canada
  • Research Site
    Kingston, Ontario K7L 2V7, Canada
  • Research Site
    Montreal, Quebec H1T 1C8, Canada
  • Research Site
    Montreal, Quebec H2X 0C1, Canada
  • Research Site
    Montreal, Quebec H4A 3J1, Canada
  • Research Site
    Montreal, Quebec H4J 1C5, Canada
  • Research Site
    Québec, Quebec G1V 4G5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06092970
Lead sponsor
Renibus Therapeutics, Inc.
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Oct 16, 2023
Primary completion
Feb 6, 2026
Completion
Feb 6, 2026
Last update
Aug 13, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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