Repletion of Ergothioneine in Patients With Kidney Failure

NCT06487546 | Recruiting

• 1 other identifier: 75743
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• erythrocyte levels of ergothioneine

  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 Outcomes (1)

• plasma levels of ergothioneine

  weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)

Study Arms (2)

Ergothioneine

EXPERIMENTAL

Ergothioneine (range 5 mg to 25 mg) oral daily for up to 12 weeks

Dietary Supplement: Ergothioneine

Placebo

PLACEBO COMPARATOR

Matching placebo oral daily for up to 12 weeks

Other: Placebo

Interventions

Ergothioneine DIETARY_SUPPLEMENT

Participants will receive ergothioneine capsule daily for 12 weeks.

Ergothioneine

Placebo OTHER

Participants will receive placebo capsule daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kidney failure receiving hemodialysis or peritoneal dialysis

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Veterans Affairs Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 36623925 BACKGROUND

• Chen 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.

  PMID: 37561026 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ergothioneine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Histidine; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Tammy Sirich, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy Sirich, MD

CONTACT

650-493-5000; tsirich@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)