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Study on the safety of hydrogen inhalation in hemodialysis patients.

Exploratory interventional study on the safety of hydrogen inhalation in patients on maintenance hemodialysis.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061240132
Enrollment
10
Registered
2025-03-07
Start date
2025-03-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease G5D (under hemodialysis) CKDG5D, Hemodialysis

Interventions

Hydrogen inhalation (250 mL/min) for 24 weeks during haemodialysis (3 times a week for approx. 4 hr/treatment).
D01.268.406

Sponsors

Shibuya Masaki
Lead Sponsor
Sano Motoaki
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who have been on maintenance haemodialysis (including haemodialysis and haemodiafiltration) for at least 3 months. (2) Patients who are at least 18 years of age at the time of consent . (3) Gender Not applicable. (4) Inpatient or outpatient Not applicable. (5) Patients who have been fully informed of the study and have given their voluntary written consent based on full understanding.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of or complicated with malignant tumours. However, patients with a history of malignant tumours who are untreated and have not relapsed for more than 5 years at the time of obtaining consent may be included. (2) Patients complicated with unstable angina or non-compensated heart failure. (3) Patients complicated with cirrhosis or liver failure. (4) Patients who require oxygen inhalation during dialysis. (5) Patients with frequent hypotension during dialysis (6)Patients who are judged to be inappropriate as research subjects by the principal investigator (co-principal investigator).

Design outcomes

Primary

MeasureTime frame
Safety (adverse events)

Secondary

MeasureTime frame
Relationship between hydrogen dosage and hydrogen blood concentration, expiratory gas analysis and ABI/CAVI, effect on anemia, effect on fatigue

Contacts

Public ContactMasaki Shibuya

Yamaguchi University Hospital

mshibuya@yamaguchi-u.ac.jp+81-836-22-2248

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026