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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thalidomide group | Experimental | Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. |
|
| Placebo group | Placebo Comparator | Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug | Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus score | Comparison of pruritus score between treatment group and control group at 12 weeks | 12 weeks |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renhua Lu, Doctor | Contact | 86-13361958582 | lurenhua1977@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Renhua Lu, Doctor | Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University | Principal Investigator |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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Prospective, randomized, placebo-controlled
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| Placebo | Drug | Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day |
|
| Pittsburgh sleep quality score |
Comparison of Pittsburgh sleep quality score between treatment group and control group |
| 12 weeks |
| 12 weeks |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |