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Study on the efficacy and safety of different drugs in treating restless leg syndrome and itching in maintenance hemodialysis patients

Study on the efficacy and safety of different drugs in treating restless leg syndrome and itching in maintenance hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119196
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Restless leg syndrome and itching in maintenance hemodialysis patients

Interventions

Gabapentin group:100mg~300mg/time, maximum not exceeding 500mg, orally administered after dialysis, 3 times a week.
Pregabalin Group:75mg~150mg/time, orally taken after dialysis, 3 times a week.
Nefarafenib group:2.5ug-5.0ug/time, take orally after dinner or before bedtime, once a day.

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18-75 years old, gender not limited; 2.Maintenance hemodialysis for >= 3 months, 3 times a week; 3.Patients with moderate to severe RLS and/or UP who meet the diagnostic criteria of the International RLS Research Group; 4.Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Allergies to research drugs; 2.Severe liver dysfunction, infection, and malignant tumors; 3.Pregnant or lactating women; 4.Unable to cooperate due to mental illness or cognitive impairment; 5.Recently participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Change in IRLS score from baseline after 8 weeks of treatment;

Secondary

MeasureTime frame
Changes in VAS score;Incidence of adverse events;Laboratory index changes;

Countries

China

Contacts

Public ContactHaibo Yu

The Second Hospital of Tianjin Medical University

yuhaibo2001@126.com+86 135 1228 4415

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026