Phase
Condition
Renal Failure
Kidney Failure
Kidney Disease
Treatment
Placebo
MIB-626
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years
Scheduled to undergo elective isolated CABG surgery with cardiopulmonary bypass (CPB)
At increased risk of postoperative complications based on ≥1 of the following:
Age ≥65 years
eGFR <45 ml/min/1.73m2
Documented history of congestive heart failure or left ventricular ejectionfraction (LVEF) ≤40% within 6 months before surgery
Diabetes mellitus and urine albumin-to-creatinine ratio >30 mg/g creatinine
Peripheral arterial disease
Anemia, defined as hemoglobin <10 g/dl
Prior cardiac surgery
Exclusion
Exclusion Criteria:
Any of the following laboratory abnormalities at the time of screening:
ALT >3-fold the upper limit of normal
eGFR <30 ml/min/1.73m2 or ESKD on dialysis
Hemoglobin <8 g/dl
History of gastric bypass or malabsorption
Active alcohol or illicit substance use in the prior 6 months
Participation in an investigational trial to evaluate pharmaceuticals or biologicswithin the past 3 months or 5 half-lives, whichever is shorter
Pregnant or breast-feeding
Unwillingness to use contraception while taking study drug and for 8 weeks after thelast dose for women of reproductive age or non-sterilized male participants who aresexually active with a female partner of childbearing potential
Current use of niacin >100 mg/day or NMN, nicotinamide, or nicotinamide riboside atany dose
Conflict with other research studies
Any condition which, in the judgement of the investigator, might increase the riskto the participant
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting

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