A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Phase 4

• Conditions: Thalidomide; Haemodialysis; Uremic Pruritus
• Interventions: Drug: Placebo; Drug: Thalidomide

• Registration Number: NCT05525234
• Lead Sponsor: RenJi Hospital

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of thalidomide in the treatment of refractory uremic pruritus in maintenance hemodialysis patients.

Detailed Description

A prospective, randomized, double-blind, placebo-controlled study was conducted to explore the efficacy and safety of thalidomide in the treatment of refractory urmia pruritus.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-30
• Last Update Submitted: 2022-08-30
• Study First Posted: 2022-09-01
• Last Update Posted: 2022-09-01
• Study Start: 2022-09-15
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Maintenance hemodialysis patients (≥3 month), 3 times/week, 4 hours/session
• spKT/V≥1.2
• The diagnosis was refractory urmia pruritus and pruritus score ≥8 score
• Patients with sleep disorders need to stop sleeping pills
• Be able to complete the form by yourself or with the help of others
• Informed consent

Exclusion Criteria

• Participants in other clinical trials within 1 month
• People with thalidomide allergy
• Accompanied by severe calcium and phosphorus metabolism disorder (serum calcium≥3.0mmol/L or Serum phosphorus≥2.8mmol/L or Serum iPTH≥800pg/mL)
• Patients with other medical conditions that cause itchy skin
• With severe systemic infection, severe anemia and other serious complications
• Patients with peripheral neuropathy
• Other serious systemic diseases include systemic lupus erythematosus, multiple myeloma, thrombotic microangiopathy, and extensive metastasis of malignant tumors
• Patients with a history of thromboembolism were excluded from PICC-induced thrombosis
• Pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.
Thalidomide group	Thalidomide	Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Primary Outcome Measures

Name	Time	Method
Pruritus score	12 weeks	Comparison of pruritus score between treatment group and control group at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality score	12 weeks	Comparison of Pittsburgh sleep quality score between treatment group and control group
Efficacy index and response rate	12 weeks	Comparison of efficacy index and response rate between treatment group and control group. Efficacy index (%)=(Total score before treatment-Total score after treatment）/Total score before treatment×100%, Response rate: Efficacy index ≥30% is effective; Efficacy index \<30% is noneffective.