A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Uremic Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05525234
• Other study ID #: 2022.06.15
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 15, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: August 2022
• Source: RenJi Hospital
• Contact: Renhua Lu, Doctor
• Phone: 86-13361958582
• Email: lurenhua1977[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemodialysis
• Pruritus
• Thalidomide
• Uremic Pruritus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Security Index	Comparison of vital signs including breathing (breaths per minute), heart rate (beats per minute), blood pressure (mmHg), laboratory tests including white blood cell count (×109/L), hemoglobin (g/L), alanine transaminase (IU/L), aspertate Aminotransferase(IU/L), blood glucose (mmol/L), albumin (g/L), high sensitivity C-reactive protein (mg/L) and so on and severity of adverse events assessed according to CTC-AE 4.0 criteria between the treatment and control groups	12 weeks
Primary	Pruritus score	Comparison of pruritus score between treatment group and control group at 12 weeks	12 weeks
Secondary	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
Secondary	Pittsburgh sleep quality score	Comparison of Pittsburgh sleep quality score between treatment group and control group	12 weeks