Repletion of Ergothioneine in Patients With Kidney Failure

March 26, 2026 updated by: Tammy Lisa Sirich, Stanford University
Dialysis removes potentially harmful chemicals from the blood but can also remove potentially valuable chemicals. One potentially valuable chemical called ergothioneine, which comes from the diet, is low in the blood of people receiving dialysis. For this research study, the investigators hope to learn how well a daily ergothioneine supplement will replenish the levels in the blood of people with kidney failure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Veterans Affairs Palo Alto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • kidney failure receiving hemodialysis or peritoneal dialysis

Exclusion Criteria:

  • blood transfusion within 90 days
  • taking supplements which contain ergothioneine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ergothioneine
Ergothioneine (range 5 mg to 25 mg) oral daily for up to 12 weeks
Dietary supplement: Ergothioneine
Participants will receive ergothioneine capsule daily for 12 weeks.
Placebo Comparator: Placebo
Matching placebo oral daily for up to 12 weeks
Other: Placebo
Participants will receive placebo capsule daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
erythrocyte levels of ergothioneine
Time Frame: weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)
ergothioneine levels will be measured in whole blood
weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma levels of ergothioneine
Time Frame: weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)
ergothioneine levels will be measured in plasma
weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Tammy Sirich, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esrd

Clinical Trials on Ergothioneine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe