Haemodialysis, Thalidomide, Uremic Pruritus
Conditions
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.
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
DRUGThalidomide
Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day
DRUGPlacebo
Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, randomized, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus score | 12 weeks | Comparison of pruritus score between treatment group and control group at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy index and response rate | 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 | 12 weeks | Comparison of Pittsburgh sleep quality score between treatment group and control group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Security Index | 12 weeks | 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 |
Contacts
Primary ContactRenhua Lu, Doctor
Outcome results
None listed