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Can a single infusion protect the heart and kidneys after surgery?

NCT ID NCT06092970

Disease control Sponsor: Renibus Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This extension study follows people who completed an earlier trial (REN-007) to see how they fare for up to 12 months after cardiac surgery. Researchers will track quality of life and serious complications like kidney disease, heart attack, stroke, and hospital readmissions. Participants received either an investigational drug called RBT-1 or a placebo during the original study. The goal is to understand whether RBT-1 can reduce long-term health problems after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RBT-1 (an investigational drug given intravenously) or placebo
What this could lead to
If successful, this study could show that RBT-1 reduces serious complications after cardiac surgery, such as kidney injury, heart problems, and hospital readmissions.
What could go wrong
This is an extension study, so results depend on the earlier trial's outcomes. The drug may not show long-term benefits, and there are risks of side effects from the intravenous administration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

353 people

The number who actually took part.

Started

Oct 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post-operative complications in cardiac surgery

Contacts and locations

Locations

  • New York Presbyterian-Queens

    Flushing, New York, 11355, 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

  • 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

  • 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