HaemodialysisPhase 4NCT05525234
A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus
A Phase 4 study testing Thalidomide in people with Haemodialysis and Uremic Pruritus, run by RenJi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Haemodialysis, Uremic Pruritus, Thalidomide
- What is being tested?
- Thalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2022to 31 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Haemodialysis, Uremic Pruritus, Thalidomide
- Being tested
- Thalidomide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day
PlaceboDrug
Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide group | Experimental | Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. Receives: Drug: Thalidomide |
| Placebo group | Placebo comparator | Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus score
Comparison of pruritus score between treatment group and control group at 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
Pittsburgh sleep quality score
Comparison of Pittsburgh sleep quality score between treatment group and control group
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start15 Sep 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renhua Lu, Doctor, Principal investigator, Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525234
- Sponsor's protocol ID
- 2022.06.15
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled Study of Thalidomide in the Treatment of Refractory Uremic Pruritus
- ClinicalTrials.gov ID
- NCT05525234
- Acronym / sponsor ID
- 2022.06.15
- Conditions
- Haemodialysis, Uremic Pruritus, Thalidomide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Thalidomide group | Experimental | Drug: ThalidomideThalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. |
| Placebo group | Placebo comparator | Drug: PlaceboPalacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThalidomideStart with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day | Drug | Thalidomide group |
| PlaceboStart with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day | Drug | Placebo group |
Primary outcome
Pruritus score
Time frame: 12 weeks
Comparison of pruritus score between treatment group and control group at 12 weeks
2 secondary outcomes
Efficacy index and response rate
Time frame: 12 weeks
Pittsburgh sleep quality score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renhua Lu, Doctor principal investigator
Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thalidomide in people with Haemodialysis and Uremic Pruritus, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renhua Lu, Doctor (86-13361958582, lurenhua1977@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.