Acute Kidney InjuryNCT07739290
NAD Supplementation to Reduce the Incidence of Cardiac Surgery Associated Acute Kidney Injury
A study testing Nicotinamide (NAM) in people with Acute Kidney Injury, run by Beth Israel Deaconess Medical Center.
Trial summary
The purpose of this single-center, randomized, double-blinded placebo-controlled pilot trial is to demonstrate feasibility and help design a larger trial to assess the effectiveness of nicotinamide (NAM) supplementation in reducing risk of post-operative AKI in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Nicotinamide (NAM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Undergoing coronary artery bypass graft (CABG) and/or valve surgery with cardiopulmonary bypass (CPB) at BIDMC. Includes combination surgeries that involve CABG and/or valve plus other procedures (e.g., Maze procedure, aortic aneurysm repair).
- AKI risk score ≥6 at the time of screening
Who cannot join
- History of AKI in the seven days prior to surgery, defined as any of the following:
- Increase in serum creatinine ≥0.3 mg/dl in 48h
- Increase in serum creatinine ≥50% in 7d (if no value available in last 7d, use most recent value in last 3 months)
- Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via Foley catheter)
- Receipt of renal replacement therapy (RRT) within 7d
- Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
Show all 12Show fewer
- Pregnant or breastfeeding*
- Positive COVID test in the last 10 days.
- Prisoner or institutionalized
- Existing or anticipated durable VAD
- 8. Conflict with other studies
- 9. Previous usage of nicotinamide supplements in the past 30 days
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this single-center, randomized, double-blinded placebo-controlled pilot trial is to demonstrate feasibility and help design a larger trial to assess the effectiveness of nicotinamide (NAM) supplementation in reducing risk of post-operative AKI in patients undergoing cardiac surgery.
Read the detailed description
This single-center, randomized, double-blind, placebo-controlled trial will serve as a pilot for a larger study that aims to assess the efficacy of nicotinamide in reducing ischemia-reperfusion injury and acute kidney injury (AKI) in patients undergoing cardiac surgery. A total of 20 patients will be randomized in a 1:1 ratio to receive either a one-time dose of NAM 3000 mg or a matching placebo on the morning of surgery. Safety assessments and clinical outcomes will be monitored for 2 days (> 5 half-lives) . Blood samples will be collected from patients at up to two time points: preoperatively (after insertion of an arterial line [for blood] and intraoperatively at the end of CPB. Urine samples will also be collected at two timepoints: after insertion of the foley catheter but prior to incision, and on the morning of post-operative day 1. Discarded tissue specimens will be collected from patients at two time points: initially when excised pre-bypass, and another post-bypass, depending on the tissue availability and as a regular part of the surgery. Time points will be recorded for all the collections.
- Conditions
- Acute Kidney Injury
- Being tested
- Nicotinamide (NAM), Placebo control
- Keywords
- Acute kidney injury, nicotinamide adenine dinucleotide, cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide (NAM)Dietary supplement
A one time 3000 mg nicotinamide dose administered orally on the morning of cardiac surgery
Placebo controlDietary supplement
A visually identically placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Nicotinamide | Experimental | 3000 mg nicotinamide administered the morning of surgery Receives: Dietary Supplement: Nicotinamide (NAM) |
| Control | Placebo comparator | Placebo administered orally the morning of surgery Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative day 1 urinary KIM-1
Measurement of urinary KIM-1 pre-bypass and on post-operative day 1 compared via t-test.
Measured: From enrollment to 1 day post cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Robitaille, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739290
- Sponsor's protocol ID
- 2025P000524
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAD Supplementation to Reduce the Incidence of Cardiac Surgery Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07739290
- Acronym / sponsor ID
- 2025P000524
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, nicotinamide adenine dinucleotide, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this single-center, randomized, double-blinded placebo-controlled pilot trial is to demonstrate feasibility and help design a larger trial to assess the effectiveness of nicotinamide (NAM) supplementation in reducing risk of post-operative AKI in patients undergoing cardiac surgery.
Detailed description
This single-center, randomized, double-blind, placebo-controlled trial will serve as a pilot for a larger study that aims to assess the efficacy of nicotinamide in reducing ischemia-reperfusion injury and acute kidney injury (AKI) in patients undergoing cardiac surgery. A total of 20 patients will be randomized in a 1:1 ratio to receive either a one-time dose of NAM 3000 mg or a matching placebo on the morning of surgery. Safety assessments and clinical outcomes will be monitored for 2 days (> 5 half-lives) . Blood samples will be collected from patients at up to two time points: preoperatively (after insertion of an arterial line [for blood] and intraoperatively at the end of CPB. Urine samples will also be collected at two timepoints: after insertion of the foley catheter but prior to incision, and on the morning of post-operative day 1. Discarded tissue specimens will be collected from patients at two time points: initially when excised pre-bypass, and another post-bypass, depending on the tissue availability and as a regular part of the surgery. Time points will be recorded for all the collections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Nicotinamide | Experimental | Dietary Supplement: Nicotinamide (NAM)3000 mg nicotinamide administered the morning of surgery |
| Control | Placebo comparator | Dietary Supplement: Placebo controlPlacebo administered orally the morning of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Undergoing coronary artery bypass graft (CABG) and/or valve surgery with cardiopulmonary bypass (CPB) at BIDMC. Includes combination surgeries that involve CABG and/or valve plus other procedures (e.g., Maze procedure, aortic aneurysm repair).
- AKI risk score ≥6 at the time of screening
Key exclusion criteria (12 listed)
- History of AKI in the seven days prior to surgery, defined as any of the following:
- Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
- Pregnant or breastfeeding*
- Positive COVID test in the last 10 days.
- Prisoner or institutionalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide (NAM)A one time 3000 mg nicotinamide dose administered orally on the morning of cardiac surgery | Dietary supplement | Intervention Group - Nicotinamide |
| Placebo controlA visually identically placebo | Dietary supplement | Control |
Primary outcome
Post Operative day 1 urinary KIM-1
Time frame: From enrollment to 1 day post cardiac surgery
Measurement of urinary KIM-1 pre-bypass and on post-operative day 1 compared via t-test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide (NAM) in people with Acute Kidney Injury, run by Beth Israel Deaconess Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark J. Robitaille, MD ((617) 667-3112, mrobitai@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative day 1 urinary KIM-1 (time frame: From enrollment to 1 day post cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.