A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Double-blind, Placebo-controlled Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Conditions
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Haemodialysis, Uremic Pruritus, Thalidomide

Intervention / Treatment
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* Drug: Thalidomide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thalidomide group<br>Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. | Drug: Thalidomide<br>* Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day<br>|
| Placebo Comparator: Placebo group<br>Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. | Drug: Placebo<br>* Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus score | Comparison of pruritus score between treatment group and control group at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy index and response rate | 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. | 12 weeks | 
| Pittsburgh sleep quality score | Comparison of Pittsburgh sleep quality score between treatment group and control group | 12 weeks |