A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uremic Pruritus; Haemodialysis; Thalidomide
• Intervention / Treatment: Drug: Thalidomide; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Renhua Lu, Doctor; Phone Number: 86-13361958582; Email: lurenhua1977@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thalidomide group; Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.	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 Comparator: Placebo group; Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Renhua Lu, Doctor, Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: 2022.06.15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No