Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardi… (NCT06021457) | Clinical Trial Compass
CompletedPhase 3
Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
United States454 participantsStarted 2023-10-17
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low.
✕
What they're measuring
1
Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days).
Timeframe: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
. 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.