Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery and Sub-Study of Clinical Protocol REN-007: A Population Pharmacokinetic (popPK) Evaluation of RBT-1

Overview

About this study

The purpose of this study is 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Male or female, ≥18 years of age at Screening.
2. 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.
3. 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.
4. 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.
5. Willingness to comply with all study-related procedures and assessments.

Exclusion Criteria:

1. Surgery planned to occur \<24 hours from the start of study drug infusion.
2. 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.
3. Surgery to be performed without CPB.
4. Chronic kidney disease (CKD) requiring dialysis.
5. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low.
6. Cardiogenic shock or requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP).
7. 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.
8. Known or suspected sepsis at time of Screening.
9. Asplenia (anatomic or functional).
10. History of hemochromatosis, iron overload, or porphyria.
11. Known hypersensitivity or previous anaphylaxis to SnPP or FeS.
12. Female subject who is pregnant or breastfeeding.
13. Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion or throughout participation in REN-007.
14. In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/4/2024. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arman Arghami, M.D., M.P.H.

Open for enrollment

Contact information:

Mary Timmons CCRP

(507) 255-8772

Timmons.Mary@mayo.edu

More information

Publications

Publications are currently not available