Post-Operative Complications in Cardiac SurgeryPhase 3NCT06021457
Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
A Phase 3 study testing RBT-1 in people with Post-Operative Complications in Cardiac Surgery, run by Renibus Therapeutics, Inc. at 41 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). 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
- 454 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 17 Oct 2023to 17 Jun 2025
- Phase
- Phase 3
- 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
Who may be able to join
- Male or female, ≥18 years of age at Screening.
- Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery.
- If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation.
- If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner for the duration of their study participation, unless the subject has had a vasectomy ≥6 months prior to infusion with study drug.
- Willingness to comply with all study-related procedures and assessments.
Who cannot join
- Surgery planned to occur <24 hours from the start of study drug infusion.
- Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the Investigator at the time of Screening.
- Surgery to be performed without CPB.
- Chronic kidney disease (CKD) requiring dialysis.
- Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low.
- Cardiogenic shock or immediate requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP).
Show all 14Show fewer
- Known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma cancer of the skin.
- Known or suspected sepsis at time of Screening.
- Asplenia (anatomic or functional).
- History of hemochromatosis, iron overload, or porphyria.
- Known hypersensitivity or previous anaphylaxis to SnPP or FeS.
- Female subject who is pregnant or breastfeeding.
- Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion or throughout participation in REN-007.
- In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States31 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
Charleston, South Carolina, 29466
Research Site
Charlottesville, Virginia, 22903
Research Site
Cleveland, Ohio, 44106
Research Site
Dallas, Texas, 75390
Research Site
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
La Jolla, California, 92037
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, 48703
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, 20011
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: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.
- Being tested
- RBT-1, Placebo
- Keywords
- Cardiac Surgery, CABG, Valve, Cardiopulmonary Bypass, Preconditioning
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 | Experimental | Single IV infusion prior to cardiac surgery Receives: Drug: RBT-1 |
| Placebo | Placebo comparator | Single IV infusion prior to cardiac surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days).
The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.
Measured: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
Secondary outcomes (3)
Composite of the Number of Post-operative Complications
The number of the following post-operative complications per patient will be assessed:
- Death
- AKI requiring dialysis
- >3 days in ICU
- >24 hours on ventilator
- 30-day cardiopulmonary readmission
- Need for blood transfusion during index hospitalization
- New-onset atrial fibrillation during index hospitalization
Measured: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
ICU Days
Days in ICU
Measured: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
30-day Cardiopulmonary Readmission Rates
Readmissions due to cardiopulmonary reasons
Measured: Within 30-days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start17 Oct 2023
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized 1:1 to RBT-1 or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renibus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre Lamy, MD, Principal investigator, World Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021457
- Sponsor's protocol ID
- REN-007
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06021457
- Acronym / sponsor ID
- REN-007
- Keywords
- Cardiac Surgery, CABG, Valve, Cardiopulmonary Bypass, Preconditioning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Renibus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 1 Sep 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.
The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to RBT-1 or placebo
| Arm | Type | Receives |
|---|---|---|
| RBT-1 | Experimental | Drug: RBT-1Single IV infusion prior to cardiac surgery |
| Placebo | Placebo comparator | Drug: PlaceboSingle IV infusion prior to cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, ≥18 years of age at Screening.
- Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery.
- If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation.
- If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner for the duration of their study participation, unless the subject has had a vasectomy ≥6 months prior to infusion with study drug.
- Willingness to comply with all study-related procedures and assessments.
Key exclusion criteria (14 listed)
- Surgery planned to occur <24 hours from the start of study drug infusion.
- Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the Investigator at the time of Screening.
- Surgery to be performed without CPB.
- Chronic kidney disease (CKD) requiring dialysis.
- Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low.
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
Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days).
Time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.
3 secondary outcomes
Composite of the Number of Post-operative Complications
Time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
ICU Days
Time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
30-day Cardiopulmonary Readmission Rates
Time frame: Within 30-days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- 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.
Andre Lamy, MD principal investigator
World Health Research Institute
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RBT-1 in people with Post-Operative Complications in Cardiac Surgery, run by Renibus Therapeutics, Inc. at 41 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days). (time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable). 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 1 Aug 2025.