A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

NCT05525234 | Unknown Phase 4 DMC

• 1 other identifier: 2022.06.15
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Haemodialysis; Uremic Pruritus; Thalidomide

Outcome Measures

Primary Outcomes (1)

• Pruritus score

  Comparison of pruritus score between treatment group and control group at 12 weeks

  12 weeks

Secondary Outcomes (2)

• Efficacy index and response rate

  12 weeks

• Pittsburgh sleep quality score

  12 weeks

Other Outcomes (1)

• Security Index

  12 weeks

Study Arms (2)

Thalidomide group

EXPERIMENTAL

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

Drug: Thalidomide

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Thalidomide DRUG

Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day

Thalidomide group

Placebo DRUG

Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Interventions

Thalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Renhua Lu, Doctor

  Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renhua Lu, Doctor

CONTACT

86-13361958582; lurenhua1977@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, placebo-controlled

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: September 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: September 1, 2022

Record last verified: 2022-08