304 Participants Needed

NAD+ Augmentation for Acute Kidney Injury

(NACAM Trial)

AP
Overseen ByAli Poyan Mehr, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kaiser Permanente
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Niacinamide for treating acute kidney injury?

Research suggests that boosting NAD+ levels, which Niacinamide is a part of, may help repair DNA damage and reduce inflammation in kidney cells, potentially improving outcomes after acute kidney injury. Additionally, Niacin, another form of vitamin B3 like Niacinamide, has shown protective effects on heart and kidney function in animal studies.12345

Is NAD+ augmentation safe for humans?

Nicotinamide (a form of vitamin B3) and its related compounds, which help increase NAD+ levels, have been studied in various conditions and are generally considered safe in humans. However, specific safety data for acute kidney injury is limited, and more research is needed to confirm its safety in this context.13456

How does the drug Niacinamide differ from other treatments for acute kidney injury?

Niacinamide is unique because it aims to boost NAD+ levels, which may help repair kidney damage by improving DNA repair and reducing inflammation. This approach is different from other treatments that do not focus on enhancing NAD+ to protect the kidneys.13457

What is the purpose of this trial?

A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery

Eligibility Criteria

This trial is for adults over 18 who need non-emergency heart surgery with a pump and are at high risk of heart-related complications. Eligible participants include those with valve surgeries, weak kidney function, reduced heart pumping capacity, history of heart failure or diabetes, protein in urine, anemia, previous bypass surgery or age 65+.

Inclusion Criteria

You have certain health conditions or risk factors that could make surgery risky for your heart, such as heart valve surgery, kidney function below a certain level, weak heart pumping function, history of heart failure, diabetes requiring insulin, diabetes not requiring insulin with certain kidney function test results, low red blood cell count, previous heart bypass surgery, or being 65 years or older.
Informed consent before any study-related activities
I have had heart surgery, including valve repair or replacement.

Exclusion Criteria

I have had a kidney transplant.
I am having heart surgery without using a heart-lung machine.
My kidney function was reduced before surgery, as shown by a creatinine test.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

  • Niacinamide
  • Placebo
Trial Overview The study tests if Niacinamide (a form of vitamin B3) can prevent acute kidney injury after on-pump cardiac surgery compared to a placebo. Participants will be randomly assigned to receive either Niacinamide or a placebo in this double-blind study where neither the patients nor the researchers know who gets which treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral niacinamideExperimental Treatment1 Intervention
Group II: Matched placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials
872
Recruited
12,930,000+

Cedars-Sinai Medical Center

Collaborator

Trials
523
Recruited
165,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

In patients undergoing cardiac bypass surgery, lower levels of urine tryptophan and kynurenine were linked to the development of acute kidney injury (AKI), indicating a potential issue with the kynurenine pathway involved in NAD+ synthesis.
Despite the expectation that nicotinamide (NAM) supplementation would improve kidney health by replenishing NAD+, it did not enhance kidney NAD+ levels or improve kidney function in mouse models of ischemic-reperfusion injury, suggesting that the effectiveness of vitamin B3 derivatives in treating kidney injury may vary and requires further investigation.
Nicotinamide and acute kidney injury.Fontecha-Barriuso, M., Lopez-Diaz, AM., Carriazo, S., et al.[2021]
In a study involving male Sprague-Dawley rats, niacin treatment before and after kidney ischemia and reperfusion significantly improved cardiac function and reduced oxidative stress, indicating its protective role during kidney injury.
The results suggest that kidney I/R injury leads to cardiac dysfunction through increased lipid peroxidation and altered energy production, while niacin helps sustain mitochondrial metabolism and PGC-1α expression, which is crucial for ATP production.
Niacin ameliorates kidney warm ischemia and reperfusion injury-induced ventricular dysfunction and oxidative stress and disturbance in mitochondrial metabolism in rats.Tai, ST., Fu, YH., Yang, YC., et al.[2018]
In a study of 167 cardiac bypass surgery patients, a significant decrease in urinary tryptophan and kynurenin was observed in those who developed acute kidney injury (AKI), indicating a potential biomarker for AKI risk.
However, supplementation with nicotinamide (NAM) did not improve kidney function or outcomes in a mouse model of ischaemic AKI, suggesting that NAM may not be an effective treatment for preventing renal damage in this context.
The tryptophan pathway and nicotinamide supplementation in ischaemic acute kidney injury.Piedrafita, A., Balayssac, S., Mayeur, N., et al.[2022]

References

Nicotinamide and acute kidney injury. [2021]
Niacin ameliorates kidney warm ischemia and reperfusion injury-induced ventricular dysfunction and oxidative stress and disturbance in mitochondrial metabolism in rats. [2018]
The tryptophan pathway and nicotinamide supplementation in ischaemic acute kidney injury. [2022]
Nicotinamide Mononucleotide Attenuates Renal Interstitial Fibrosis After AKI by Suppressing Tubular DNA Damage and Senescence. [2021]
The metabolites of de novo NAD+ synthesis are a valuable predictor of acute kidney injury. [2023]
Nicotinamide Attenuates the Progression of Renal Failure in a Mouse Model of Adenine-Induced Chronic Kidney Disease. [2021]
Reduced nicotinamide mononucleotide is a new and potent NAD+ precursor in mammalian cells and mice. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security