A Phase 2 interventional study of MIB-626 and Placebo in Cardiac Surgery, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective cardiac surgery to investigate the effects of oral nicotinamide mononucleotide (NMN) administration on myocardial NAD+ concentrations and on postoperative markers of myocardial and kidney injury.
This is a phase 2a, randomized, double-blind, parallel-group, placebo-controlled clinical trial in adult patients undergoing elective cardiac surgery. A total of 90 patients will be randomized 1:1:1 to placebo or to one of two dosing regimens of NMN seven days prior to surgery as follows:
Arm A: NMN 1,000 mg PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 3 days postoperatively
Arm B: NMN 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively
Arm C: Placebo PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 3 days postoperatively
There are two major study aims:
Aim 1: Test the effect of oral NMN administration on myocardial NAD+ concentration.
Aim 2: Test the effect of oral NMN administration on postoperative myocardial and kidney injury parameters.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At increased risk of postoperative complications based on ≥1 of the following:
Exclusion Criteria:
Any of the following laboratory abnormalities at the time of screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NMN (MIB-626) 1000 mg PO daily, for 7 days preoperatively, on day of surgery, and for 3 days postoperatively
Drug: MIB-626
NMN (MIB-626) 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively
Drug: MIB-626
Placebo administered for 7 days preoperatively, on the day of surgery, and for 3 days postoperatively
Other: Placebo
An orally-administered stable crystalline tablet formulation of NMN
matching placebo tablets
NAD+ concentration in the myocardial tissue
NAD+ concentration in the myocardial tissue (right atrial appendage) obtained intraoperatively, measured using the validated NADome Quant assay
Time frame: Intraoperatively (single time point)
Intracellular levels of NAD+ and related metabolites
NAD+, NADH, and related metabolite concentrations in discarded tissue collected intraoperatively, including right atrial appendage, internal mammary artery, sternal muscle, and fat
Time frame: Intraoperatively (single time point)
Circulating levels of NAD+ and related metabolites
NAD+, NADH, and related metabolite concentrations in the circulation and in peripheral blood mononuclear cells
Time frame: Baseline to day 90
Markers of cardiac injury/dysfunction
Circulating levels of cardiac troponin I, creatine kinase MB fraction (CKMB), and N-terminal pro-B-type natriuretic peptide (NT-pro-BNP)
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
Acute kidney injury (AKI)
Incidence of acute kidney injury (AKI) defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria as any of the following: 1) urine output \<0.5 ml/kg/h for ≥6 consecutive hours (assessed within the first 48h or until the Foley catheter is removed, whichever occurs first); 2) an increase in SCr ≥0.3 mg/dl within the first 48h; 3) an increase in SCr ≥50% within the first 7 days; or 4) receipt of KRT within the first 7 days
Time frame: 7 days post-operatively
Serum creatinine (SCr)
Maximum baseline-adjusted changes in SCr
Time frame: Immediately pre-operative to 7 days post-operative
Cystatin C
Circulating levels of cystatin C
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
Neutrophil gelatinase-associated lipocalin (NGAL)
Circulating levels of measured neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
Kidney Injury Molecule-1 (KIM-1)
Circulating levels of KIM-1
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
NMN level
Plasma concentrations of NMN
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
2PY Level
Plasma concentrations of 2PY
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
N-Methylnicotinamide level
Plasma N-methylynicotinamide level
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
nicotinamide level
Plasma nicotinamide concentrations
Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) measured by a transesophageal echocardiogram (TEE)
Time frame: change from immediately preoperative to immediate postoperative
Atrial fibrillation
Frequency of new-onset atrial fibrillation. Atrial fibrillation must be confirmed on a 12-lead ECG or a rhythm strip, confirmed by a healthcare provider, or treated (either medically \[e.g., amiodarone\] or with electrical cardioversion)
Time frame: First seven days postoperatively
Vasoactive-inotropic score
The vasoactive-inotropic score is a validated method for integrating all vasoactive medications and their doses on an hourly basis into a single measure. The score ranges from 0 to 100, with higher scores indicating greater cardiovascular support needs.
Time frame: Immediately preoperatively to 24-hours post-incision
Time-to-liberation from vasoactive medications
Time (in hours) from end of cardiopulmonary bypass (CPB) to liberation from all vasopressors and inotropes.
Time frame: End of cardiopulmonary bypass to 24 hours post surgery
ICU length of stay
time to release from the ICU post-operatively
Time frame: Time in days in the ICU post-operatively, from the day of admission to the ICU postoperatively after the coronary artery bypass surgery to the time of release from ICU or date of death from any cause, up to 90 days
Plan to share: Yes — In accordance with the NIH Policy for Data Management and Sharing, as well as the NIH Genomic Data Sharing Policy, deidentified data generated from this research will be shared with the research community by depositing it in the Harvard Dataverse. This will include any large-scale genomic data generated.
Supporting information: Study protocol, Informed consent form
Time frame: Within 1 year of the end date of the study
Access criteria: Only de-identified data will be available for scientific research upon review of specific request and provision of IRB-approval.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Oct 2028, 27 months after the start.
Of 39 non-industry phase 2 interventional studies under Acute Kidney Injury, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's planned 27 months is close to that.
Counting every sponsor, half of 57 studies reached it within 29 months; a quarter within 16 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: MIB-626
Brigham and Women's Hospital →