AST-120 in Hemodialysis Patients With Uremic Pruritus

NCT04639674 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-07

No results posted yet for this study

Summary

The prevalence of cutaneous pruritus among hemodialysis patients is about 50% to 80%. There is only a handful of studies on the itchy skin of hemodialysis patients and the findings are to be validated. Effective drugs to treat cutaneous pruritus are not available yet. Hence, the purpose of the study is to eliminate the uremic toxins from the intestinal tract using AST-120 as a treatment measure to improve the symptom of the hemodialysis patients' cutaneous pruritus and discuss and assess its effectiveness. For this, the investigators will recruit 150 patients to validate the application potential of the AST-120 in the cutaneous pruritus brought about by uremia.

Conditions

  • Uremic Pruritus

Interventions

DRUG

AST-120

If no other medicines are taken usually, take AST-120 one hour after each meal with a frequency of three doses a day and one dose every administration. The drug will be taken for four weeks.

Sponsors & Collaborators

  • Tri-Service General Hospital

    collaborator OTHER
  • Tungs' Taichung Metroharbour Hospital

    collaborator OTHER
  • Chang Gung Memorial Hospital

    collaborator OTHER
  • Taichung Veterans General Hospital

    collaborator OTHER
  • Kaohsiung Medical University

    collaborator OTHER
  • Taichung Tzu Chi Hospital

    collaborator OTHER
  • Fu Jen Catholic University

    collaborator OTHER
  • Conmed Pharmaceutical & Bio-Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Po-Sung Lin, Dr. · Tungs' Taichung MeltroHarbor Hospital

  • Chia-Chao Wu, Dr. · Tri-Service General Hospital

  • Shou-Hsuan Liu, Dr. · Chang Gung Memorial Hospital

  • Yi-Wen Chiu, Dr. · Kaohsiung Medical University

  • Ming-Ju Wu, Dr. · Taichung Veterans General Hospital

  • Kuo-Cheng Lu, Dr. · Taipei Buddhist Tzu Chi Medical Foundation

  • Lin-Kuo Ko, Dr. · Taichung Tzu Chi Hospital

  • Jian-Lin Lu, Dr. · Fu Jen Catholic University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639674 on ClinicalTrials.gov