A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • Drug: Thalidomide
    • Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day
  • Drug: Placebo
    • Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day

Arms, Groups and Cohorts

  • Experimental: Thalidomide group
    • Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.
  • Placebo Comparator: Placebo group
    • Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Clinical Trial Outcome Measures

Primary Measures

  • Pruritus score
    • Time Frame: 12 weeks
    • Comparison of pruritus score between treatment group and control group at 12 weeks

Secondary Measures

  • Efficacy index and response rate
    • Time Frame: 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.
  • Pittsburgh sleep quality score
    • Time Frame: 12 weeks
    • Comparison of Pittsburgh sleep quality score between treatment group and control group

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Renhua Lu, Doctor, Principal Investigator, Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University
  • Overall Contact(s)
    • Renhua Lu, Doctor, 86-13361958582, lurenhua1977@hotmail.com

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