AST-120 in Hemodialysis Patients With Uremic Pruritus

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Conmed Pharmaceutical & Bio-Medical Corporation
• Collaborators: Chang Gung Memorial Hospital; Kaohsiung Medical University; Taichung Veterans General Hospital; Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; Tri-Service General Hospital; Tungs' Taichung Metroharbour Hospital

Criteria

Inclusion Criteria:

1. Age of the subject: Over 20 (incl.) to less than 100

2. 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.

3. The patient must have taken drugs for the treatment of the cutaneous pruritus within the past six months and the effectiveness is not significant.

4. The patient must have not used AST-120 within the past three months.

5. 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).

6. Stable hemodialysis fistulas (both Arteriovenous Fistula, Arteriovenous Graft) must be available.

7. The patient must cooperate in the implementation of the investigational drug administration plan.

8. The patient must be able to sign the Informed consent form correctly.

9. The patient must be able to communicate with the researchers and understand the details of the study project.

10. All the drugs that the patient has taken must be traceable to a prescription.

Exclusion Criteria:

1. A physician has advised the patient not to take AST-120.

2. The patient suffers from poorly controlled high blood pressure, liver disease (higher than the liver function index ALanine aminoTransferase by 2.5 times or more), cholestasis, heart disease (congestive heart failure, coronary heart disease, ischemic heart disease), brain stroke, malignant tumor, acute inflammation, acute infection, or active lung disease.

3. The patient suffers from any skin disease not attributable to uremic toxins, including allergic or mycotic dermatitis. (If necessary, visit a dermatologist for diagnosis.)

4. The serum calcium level is higher than 10.5 mg/dl, serum phosphorus level is higher than 6.5 mg/dl, hemochrome level less than 9.0 g/dl, or serum parathyroid hormone level higher than 600 pg/ml.

5. The patient is pregnant or nurses a baby.

6. The formula of the drug for cutaneous pruritus has been changed 2 weeks before the screening.

7. The skin has undergone UV irradiation or acupuncture therapy 6 weeks before the screening.

8. Excessive alcohol or drug abuse has occurred 12 weeks before the screening.

9. The patient has participated in an interventional clinical trial 2 months before the screening.

10. The patient of the clinical trial may not accept any antibiotic treatment during the screening and trial period (because antibiotics will affect the concentration of the uremic toxins).

11. The patient suffers from digestive tract motility disorder and peptic ulcer disease or esophageal varices.