CompletedPhase 4

AST-120 in Hemodialysis Patients With Uremic Pruritus

Taiwan100 participantsStarted 2020-07-02

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age of the subject: Over 20 (incl.) to less than 100
. The patient must have undergone regular hemodialysis (excluding Hemodiafiltration or HDF) three times a week for at least six consecutive months and the Kt/V value, an indicator of the hemodialysis efficiency measured by urea nitrogen reduction ratio, must be greater than 1.2.
. The patient must have taken drugs for the treatment of the cutaneous pruritus within the past six months and the effectiveness is not significant.
. The patient must have not used AST-120 within the past three months.
. The average VAS (Visual Analogue Scale) score of three itchy skin assessments during the screening period must be greater than or equal to 4 (VAS≧4).
. Stable hemodialysis fistulas (both Arteriovenous Fistula, Arteriovenous Graft) must be available.
. The patient must cooperate in the implementation of the investigational drug administration plan.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analog scale

Timeframe: Change From Baseline in VAS at 2 Months

Trial details

NCT IDNCT04639674

SponsorConmed Pharmaceutical & Bio-Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-31

View on ClinicalTrials.gov More Uremic Pruritus trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age of the subject: Over 20 (incl.) to less than 100
. The patient must have undergone regular hemodialysis (excluding Hemodiafiltration or HDF) three times a week for at least six consecutive months and the Kt/V value, an indicator of the hemodialysis efficiency measured by urea nitrogen reduction ratio, must be greater than 1.2.
. The patient must have taken drugs for the treatment of the cutaneous pruritus within the past six months and the effectiveness is not significant.
. The patient must have not used AST-120 within the past three months.
. The average VAS (Visual Analogue Scale) score of three itchy skin assessments during the screening period must be greater than or equal to 4 (VAS≧4).
. Stable hemodialysis fistulas (both Arteriovenous Fistula, Arteriovenous Graft) must be available.
. The patient must cooperate in the implementation of the investigational drug administration plan.

AST-120 in Hemodialysis Patients With Uremic Pruritus

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

AST-120 in Hemodialysis Patients With Uremic Pruritus

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria