A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 4

Conditions: Uremic Pruritus; Haemodialysis; Thalidomide

Treatments: Drug: Placebo; Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT05525234

2022.06.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Thalidomide group

Experimental group

Description:

Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Treatment:

Drug: Thalidomide

Placebo group

Placebo Comparator group

Description:

Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Treatment:

Drug: Placebo