EsrdNCT06487546
Repletion of Ergothioneine in Patients With Kidney Failure
A study testing Ergothioneine in people with Esrd, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esrd
- What is being tested?
- Ergothioneine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to Dec 2030
- 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
- kidney failure receiving hemodialysis or peritoneal dialysis
Who cannot join
- blood transfusion within 90 days
- taking supplements which contain ergothioneine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Veterans Affairs Palo Alto
Palo Alto, California, 94304
Tammy Sirich, 650-493-5000, tsirich@stanford.edu
About this study
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.
- Conditions
- Esrd
- Being tested
- Ergothioneine, Placebo
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgothioneineDietary supplement
Participants will receive ergothioneine capsule daily for 12 weeks.
PlaceboOther
Participants will receive placebo capsule daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ergothioneine | Experimental | Ergothioneine (range 5 mg to 25 mg) oral daily for up to 12 weeks Receives: Dietary Supplement: Ergothioneine |
| Placebo | Placebo comparator | Matching placebo oral daily for up to 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
erythrocyte levels of ergothioneine
ergothioneine levels will be measured in whole blood
Measured: weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)
Secondary outcomes (1)
plasma levels of ergothioneine
ergothioneine levels will be measured in plasma
Measured: weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EsrdStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammy Lisa Sirich, Stanford University
- Investigators
- Tammy Sirich, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487546
- Sponsor's protocol ID
- 75743
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halliwell B, Tang RMY, Cheah IK. Diet-Derived Antioxidants: The Special Case of Ergothioneine. Annu Rev Food Sci Technol. 2023 Mar 27;14:323-345. doi: 10.1146/annurev-food-060822-122236. Epub 2023 Jan 9.
PubMed 36623925Chen L, Zhang L, Ye X, Deng Z, Zhao C. Ergothioneine and its congeners: anti-ageing mechanisms and pharmacophore biosynthesis. Protein Cell. 2024 Feb 29;15(3):191-206. doi: 10.1093/procel/pwad048.
PubMed 37561026
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repletion of Ergothioneine in Patients With Kidney Failure
- ClinicalTrials.gov ID
- NCT06487546
- Acronym / sponsor ID
- 75743
- Conditions
- Esrd
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Jul 2024 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergothioneine | Experimental | Dietary Supplement: ErgothioneineErgothioneine (range 5 mg to 25 mg) oral daily for up to 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo oral daily for up to 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- kidney failure receiving hemodialysis or peritoneal dialysis
Key exclusion criteria (2 listed)
- blood transfusion within 90 days
- taking supplements which contain ergothioneine
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 |
|---|---|---|
| ErgothioneineParticipants will receive ergothioneine capsule daily for 12 weeks. | Dietary supplement | Ergothioneine |
| PlaceboParticipants will receive placebo capsule daily for 12 weeks. | Other | Placebo |
Primary outcome
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
1 secondary outcome
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)
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 1 Apr 2026.
- Background: PubMed 36623925Halliwell B, Tang RMY, Cheah IK. Diet-Derived Antioxidants: The Special Case of Ergothioneine. Annu Rev Food Sci Technol. 2023 Mar 27;14:323-345. doi: 10.1146/annurev-food-060822-122236. Epub 2023 Jan 9.
- Background: PubMed 37561026Chen L, Zhang L, Ye X, Deng Z, Zhao C. Ergothioneine and its congeners: anti-ageing mechanisms and pharmacophore biosynthesis. Protein Cell. 2024 Feb 29;15(3):191-206. doi: 10.1093/procel/pwad048.
- Individual participant dataSharing planned: No
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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.
Tammy Sirich, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergothioneine in people with Esrd, run by Stanford University at 1 site in United States.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tammy Sirich, MD (650-493-5000, tsirich@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487546, which also lists 2 linked publications.
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 1 Apr 2026.