100 Participants Needed

Ergothioneine for Chronic Renal Failure

TS
Overseen ByTammy Sirich, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a daily supplement of ergothioneine can improve blood levels in people with kidney failure undergoing dialysis. Dialysis often removes beneficial chemicals along with harmful ones, and patients typically have low levels of ergothioneine, which is usually obtained through diet. The trial aims to determine if ergothioneine supplementation can replenish its blood levels. Researchers seek participants with kidney failure who are currently receiving either hemodialysis or peritoneal dialysis. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of ergothioneine supplementation for dialysis patients.

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

The trial information does not specify if you need to stop your current medications. However, you cannot take supplements that contain ergothioneine.

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

Research has shown that ergothioneine is generally safe. The FDA has approved it for use in food, indicating it is unlikely to cause harm when consumed in normal amounts. This approval relies on existing safety data and its use in foods.

Studies also indicate that ergothioneine serves as a helpful antioxidant. Levels are often low in people undergoing dialysis, and restoring it may help manage kidney damage. Although specific clinical data on its safety for individuals with kidney failure is lacking, its approval for food use suggests it is safe for humans.12345

Why are researchers excited about this trial?

Most treatments for chronic renal failure focus on managing symptoms or slowing disease progression through diet, medication, or dialysis. But Ergothioneine, a naturally occurring amino acid derivative, offers a fresh approach. Unlike standard therapies, Ergothioneine is known for its antioxidant properties, potentially reducing oxidative stress that damages kidney cells. Researchers are excited because it could protect kidneys at a molecular level, offering a new way to improve outcomes in chronic renal failure.

What evidence suggests that ergothioneine might be an effective treatment for chronic renal failure?

Research has shown that ergothioneine, a strong antioxidant, is often low in people on dialysis. One study found that dialysis patients had significantly less of this antioxidant in their blood. In another study, ergothioneine protected kidney function in mice with kidney problems. Additionally, taking about 8 mg of ergothioneine daily effectively raised blood levels in people. This trial will investigate the effects of ergothioneine, administered in doses ranging from 5 mg to 25 mg daily for up to 16 weeks, to assess its potential in replacing important nutrients lost during dialysis.12467

Are You a Good Fit for This Trial?

This trial is for individuals with kidney failure who are currently receiving hemodialysis or peritoneal dialysis. It aims to include those who may have low levels of a dietary chemical called ergothioneine due to their dialysis treatment.

Inclusion Criteria

I am on dialysis for kidney failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily ergothioneine supplement for up to 16 weeks

16 weeks
Visits at weeks 1, 2, 4, 8, 12, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Visits at weeks 20 and 24

What Are the Treatments Tested in This Trial?

Interventions

  • Ergothioneine

Trial Overview

The study is testing the effectiveness of a daily supplement of ergothioneine in replenishing its blood levels in patients undergoing dialysis for kidney failure. The focus is on whether this supplement can restore what's lost during dialysis.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ErgothioneineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Depletion by Hemodialysis of the Antioxidant Ergothioneine

Ergothioneine, a potentially valuable antioxidant, is markedly depleted in the erythrocytes and plasma of people receiving hemodialysis. These findings motivate ...

Proteomic analysis reveals the potential mechanism of ...

Results showed that EGT significantly mitigated renal damage in AKI-CKD mice. Proteomic analysis identified 35 differentially expressed proteins (DEPs) ...

Repletion of Ergothioneine in Patients With Kidney Failure

For this research study, we hope to learn how well a daily ergothioneine supplement will replenish the levels in the blood of people with kidney failure.

Estimation and Validation of an Effective Ergothioneine ...

Our results showed that 8 mg/day of EGT for 16 weeks was optimal for attaining an effective plasma EGT concentration. In Study 2, a randomized, ...

Ergothioneine: an underrecognised dietary micronutrient ...

In humans, blood levels of ergothioneine decline after the age of 60 years, and lower levels of ergothioneine are associated with more rapid cognitive decline.

Ergothioneine

Progression of chronic kidney disease (CKD) has also been correlated with decreasing blood levels of ergothioneine, with levels being restored following kidney ...

GRAS Notice -Ergothioneine

ergothioneine is generally recognized as safe for use in food given the regulatory and safety data available. E. Conclusion. In consideration ...