Post-Operative Complications in Cardiac SurgeryNCT06092970
An Evaluation of Patient Reported Outcomes and Clinical Outcomes
An observational study of Post-Operative Complications in Cardiac Surgery, run by Renibus Therapeutics, Inc. at 39 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Complications in Cardiac Surgery
- What is being tested?
- RBT-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 353 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 16 Oct 2023to 6 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who complete the Phase 3 REN-007 study are eligible to participate in the Extension Study.
Who may be able to join
- Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States29 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Athens, Georgia, 30606
Research Site
Atlanta, Georgia, 30342
Research Site
Atlantis, Florida, 33462
Research Site
Boston, Massachusetts, 02115
Research Site
Charlottesville, Virginia, 22903
Research Site
Cleveland, Ohio, 44106
Research Site
Dallas, Texas, 75390
New York Presbyterian-Queens
Flushing, New York, 11355
Research Site
Fort Wayne, Indiana, 46804
Research Site
Gainesville, Florida, 32608
Research Site
Houston, Texas, 77030
Research Site
Huntsville, Alabama, 35801
Research Site
Indianapolis, Indiana, 46202
Research Site
Indianapolis, Indiana, 46237
Research Site
Kansas City, Kansas, 66160
Research Site
Lansing, Michigan, 48879
Research Site
Midland, Michigan, 48670
Research Site
Nashville, Tennessee, 37203
Research Site
Raleigh, North Carolina, 27610
Research Site
Rochester, Minnesota, 55905
Research Site
Royal Oak, Michigan, 48073
Research Site
San Antonio, Texas, 78229
Research Site
San Francisco, California, 94107
Research Site
St Louis, Missouri, 63310
Research Site
Stanford, California, 94305
Research Site
Toledo, Ohio, 43606
Research Site
Washington D.C., District of Columbia, 20010
Research Site
Winston-Salem, North Carolina, 27157
Canada10 sites
Research Site
Hamilton, Ontario, L8L 2X2
Research Site
Kelowna, British Columbia, V1Y 0C5
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Montreal, Quebec, H1T 1C8
Research Site
Montreal, Quebec, H2X 0C1
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Québec, Quebec, G1V 4G5
Research Site
Saint John, New Brunswick, E2L 4L2
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
Official title: 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
- Being tested
- RBT-1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBT-1Drug
Intravenous administration
PlaceboDrug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| RBT-1 | Patients undergoing CABG, valve, or combined CABG/valve surgery Receives: Drug: RBT-1 | |
| Placebo | Patients undergoing CABG, valve, or combined CABG/valve surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation
To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire
Measured: 12 Months Post-Cardiac Surgery
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
Measured: 12 Months Post-Cardiac Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start16 Oct 2023
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Why it stopped: REN-007 main study failed to meet primary objectives, therefore this extension study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Complications in Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renibus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092970
- Sponsor's protocol ID
- REN-007E
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06092970
- Acronym / sponsor ID
- REN-007E
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: REN-007 main study failed to meet primary objectives, therefore this extension study was terminated.
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Renibus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBT-1 | – | Drug: RBT-1Patients undergoing CABG, valve, or combined CABG/valve surgery |
| Placebo | – | Drug: PlaceboPatients undergoing CABG, valve, or combined CABG/valve surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who complete the Phase 3 REN-007 study are eligible to participate in the Extension Study.
Key inclusion criteria (1 listed)
- Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBT-1Intravenous administration | Drug | RBT-1 |
| PlaceboIntravenous administration | Drug | Placebo |
Primary outcome
Evaluation
Time frame: 12 Months Post-Cardiac Surgery
To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire
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
Results and safety
The study was stopped early (reason given: REN-007 main study failed to meet primary objectives, therefore this extension study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Operative Complications in Cardiac Surgery, run by Renibus Therapeutics, Inc. at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: REN-007 main study failed to meet primary objectives, therefore this extension study was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation (time frame: 12 Months Post-Cardiac Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.