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A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Primary Purpose

Haemodialysis, Uremic Pruritus, Thalidomide

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Thalidomide

Placebo

About this trial

This is an interventional treatment trial for Haemodialysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thalidomide group

Placebo group

Arm Description

Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Outcomes

Primary Outcome Measures

Pruritus score

Comparison of pruritus score between treatment group and control group at 12 weeks

Secondary Outcome Measures

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.

Pittsburgh sleep quality score

Comparison of Pittsburgh sleep quality score between treatment group and control group

Full Information

NCT ID

NCT05525234

First Posted

August 29, 2022

Last Updated

August 30, 2022

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05525234

Brief Title

A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Official Title

A Prospective, Randomized, Double-blind, Placebo-controlled Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 15, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haemodialysis, Uremic Pruritus, Thalidomide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Prospective, randomized, placebo-controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thalidomide group

Arm Type

Experimental

Arm Description

Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.

Intervention Type

Drug

Intervention Name(s)

Thalidomide

Intervention Description

Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day

Primary Outcome Measure Information:

Title

Pruritus score

Description

Comparison of pruritus score between treatment group and control group at 12 weeks

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Efficacy index and response rate

Description

Time Frame

12 weeks

Title

Pittsburgh sleep quality score

Description

Comparison of Pittsburgh sleep quality score between treatment group and control group

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Security Index

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Renhua Lu, Doctor

Phone

86-13361958582

lurenhua1977@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renhua Lu, Doctor

Organizational Affiliation

Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

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