Nicotinamide Riboside for Kidney Disease

MC
BF
Overseen ByBeverly Farmer, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Colorado, Denver
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if nicotinamide riboside, a supplement, can reduce the risk of heart disease in individuals with chronic kidney disease (CKD). The study will examine whether this supplement can lower artery stiffness and blood pressure, both linked to heart issues. Participants will take either the supplement or a placebo for three months. The trial suits those diagnosed with stage III or IV CKD who have stable blood pressure and have maintained a steady weight for the past three months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressant agents or long-term oral glucocorticoids, you may not be eligible to participate.

Is there any evidence suggesting that nicotinamide riboside is likely to be safe for humans?

Research has shown that nicotinamide riboside, the treatment being tested, is generally safe. In studies, participants taking nicotinamide riboside did not experience significant side effects compared to those taking a placebo, which is a harmless pill. For example, one study found no major differences in negative effects between the groups. Additionally, nicotinamide riboside has received GRAS status, meaning "generally recognized as safe," indicating that experts consider it safe to consume based on current evidence. Even at higher doses, such as 3000 mg daily, nicotinamide riboside has proven to be safe. In summary, existing research supports that nicotinamide riboside is well-tolerated and has a good safety profile.12345

Why do researchers think this study treatment might be promising?

Most treatments for kidney disease focus on managing symptoms or slowing progression with medications like ACE inhibitors, ARBs, and diuretics. But Nicotinamide Riboside works differently, targeting cellular health by boosting levels of NAD+, a molecule crucial for energy metabolism and cellular repair. Researchers are excited about Nicotinamide Riboside because it represents a novel approach by potentially enhancing the body's natural repair mechanisms, which might improve kidney function more effectively than current options. Additionally, its oral administration makes it an easy and non-invasive treatment option for patients.

What evidence suggests that nicotinamide riboside might be an effective treatment for kidney disease?

Research has shown that nicotinamide riboside, which participants in this trial may receive, can effectively increase NAD+ levels in the body. NAD+ is an important molecule that helps keep cells healthy and functioning properly. Studies have found that increasing NAD+ can reduce damage caused by free radicals and lower inflammation. In people with high blood pressure, nicotinamide riboside has been shown to make arteries less stiff and lower blood pressure. Animal studies suggest that nicotinamide riboside can protect the kidneys and reduce kidney damage. These findings support its potential to improve heart and kidney health, especially in those with chronic kidney disease.16789

Who Is on the Research Team?

MC

Michel Chonchol, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults aged 35-80 with moderate to severe chronic kidney disease (stages III or IV), who have had stable weight and blood pressure control. They must not be pregnant, planning pregnancy, or nursing, and should not have been hospitalized recently or taking certain immunosuppressants.

Inclusion Criteria

My kidney function is moderately to severely reduced but stable.
Ability to provide informed consent
My weight has been stable, with less than a 2 kg change, for the last 3 months.
See 4 more

Exclusion Criteria

I am pregnant, nursing, or planning to become pregnant.
I am on chronic dialysis for advanced kidney disease.
Special classes of subjects considered vulnerable populations will not be included in the study
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nicotinamide riboside or placebo for 3 months to assess its effects on aortic stiffness and systolic blood pressure

12 weeks
Visits every 2 weeks for monitoring and pill count

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotinamide Riboside

Trial Overview

The trial tests if nicotinamide riboside supplements can reduce arterial stiffness and high systolic blood pressure in CKD patients. It's a phase IIa study where participants are randomly given either the supplement or a placebo twice daily for three months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotinamide RibosideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Nicotinamide Riboside is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Niagen for:
🇪🇺
Approved in European Union as Niagen for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Nicotinamide Riboside—The Current State of Research and ...

Oral supplementation with NR has been shown to increase NAD+ levels in multiple tissues, along with increased SIRT activity [10,11], improved mitochondrial ...

Effects of NAD⁺ repletion with Nicotinamide riboside on ...

Our data showed that NAD⁺ repletion by NR supplementation, whether preventive or interventional, did not affect body or organ weights, and did ...

Unraveling the nexus of NAD+ metabolism and diabetic ...

The study showed that NAD+ levels were decreased in diabetic kidneys. Our study demonstrated KMO of NAD+ de novo synthesis pathway was ...

Latest UPenn Study Reveals NMN and NR Have Similar ...

Supplementing with nicotinamide mononucleotide (NMN) or nicotinamide riboside (NR) confers comparable benefits against kidney disease in male mice.

Nicotinamide Riboside: A Promising Treatment for Type 1 ...

Collectively, our data indicate decreased injury level and improved kidney function at day 4 and day 7 post‐MI following NR administration ...

Safety and Metabolism of Long-term Administration ...

There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups ...

GRAS Notice 635: Nicotinamide riboside chloride

The intake of Niagen from the intended uses specified above has been shown to be safe and GRAS based on generally available and accepted ...

What is really known about the effects of nicotinamide ...

Nicotinamide riboside may play a role in the reduction of inflammatory states and has shown some potential in the treatment of diverse severe diseases.

Nicotinamide Riboside - Uses, Side Effects, and More

Note: The FDA has not reviewed nicotinamide riboside for safety and effectiveness. ... It cannot be marketed to treat or cure a disease.