Status:
COMPLETED
Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
Lead Sponsor:
Renibus Therapeutics, Inc.
Conditions:
Post-Operative Complications in Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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). A sub-study wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2025
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT06021457
Start Date
October 17 2023
End Date
June 17 2025
Last Update
August 1 2025
Active Locations (41)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
La Jolla, California, United States, 92037
3
Research Site
San Francisco, California, United States, 94107
4
Research Site
Stanford, California, United States, 94305