A prospective, single-arm, single-center clinical study of the preliminary safety and efficacy of thalidomide in the treatment of refractory uremic pruritus

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100053515

Enrollment

Unknown

Registered

2021-11-23

Start date

2021-12-20

Completion date

Unknown

Last updated

2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urmia pruritus

Interventions

Experimental group:Thalidomide

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, no gender limitation; 2. Maintenance hemodialysis patients (regular dialysis >=3 months), 3 times/week, 4h/ time; 3. SpKT/V >=1.2; 4. Diagnosis of refractory urmia pruritus; 5. Patients with sleep disorders need to stop sleeping aids; 6. Able to complete the form by theirselves or with the help of others; 7. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants in other clinical trials within 1 month; 2. Patients with thalidomide allergy; 3. Severe calcium and phosphorus metabolism disorder (blood calcium >=3.0mmol/L or blood P>=2.8mmol/L or serum iPTH level >=800pg/mL); 4. Those who are clearly diagnosed with other diseases that cause itchy skin; 5. Patients with serious complications such as severe systemic infection and severe anemia; 6. Patients with peripheral neuropathy; 7. Patients with other serious systemic diseases; 8. Those with a history of thromboembolism, except for thrombosis caused by PICC.

Design outcomes

Primary

Measure	Time frame
Skin pruritus score efficacy index;	—

Countries

China

Contacts

Public ContactLu Renhua

Renji Hospital School of Medicine Shanghai Jiao Tong University

lurenhua1977@hotmail.com+86 13361958582

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026