A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus
NCT ID: NCT05525234
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2022-09-15
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Thalidomide group
Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.
Thalidomide
Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day
Placebo group
Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Renhua Lu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University
Central Contacts
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Other Identifiers
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2022.06.15
Identifier Type: -
Identifier Source: org_study_id
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