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A multicenter randomized open parallel group clinical study on the treatment of pruritus in hemodialysis patients with sodium thiosulfate

A multicenter randomized open parallel group clinical study on the treatment of pruritus in hemodialysis patients with sodium thiosulfate

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058021
Enrollment
Unknown
Registered
2022-03-27
Start date
2020-04-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Uremia, itchy skin

Interventions

Group 1:Sodium thiosulfate 1.92g intravenously, three times a week
Group 2:Sodium thiosulfate 3.2g intravenously, three times a week
Group 3:Sodium thiosulfate 4.48g intravenously, three times a week

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, gender unlimited; 2. Stable dialysis for more than 3 months, dialysis frequency 2-3 times/week; 3. Cognitively and mentally normal, symptoms and efficacy can be evaluated; 4. Skin pruritus was the main symptom, and the itch VAS score was >=4 points; 5. Kt/v >=1.2; 6. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. There is a kidney transplant plan in the near future; 2. Unmanageable hypertension, SBP>=180mmHg and/or DBP>=110mmHg; 3. Severe liver insufficiency, glutamic-pyruvic transaminase more than 3 times the upper limit of normal value; 4. Patients with stroke within 3 months; 5. Patients with severe hyperphosphatemia and severe parathyroidism had blood phosphorus >=3.0mmol/L and PTH>=1000pg/ml; 6. Patients currently receiving radiotherapy and chemotherapy for malignant tumors; 7. Pregnant patients; 8. Patients with acute and chronic infection; 9. Patients with known allergy to sodium thiosulfate; 10. Those who are participating in other drug clinical trials or have participated in other clinical trials within 3 months; 11. Patients deemed unsuitable for this clinical study by other researchers.

Design outcomes

Primary

MeasureTime frame
blood routine;liver function;kidney function;electrolyte;parathyroid hormone;itching score;

Countries

China

Contacts

Public ContactWang Niansong
wangniansong2012@163.com+86 18930177399

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026