AST-120 in Hemodialysis Patients With Uremic Pruritus

NCT04639674 | Completed Phase 4

• 1 other identifier: Conmed
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Visual analog scale

  Symptoms of skin itching: Visual analog scale (VAS)

  Change From Baseline in VAS at 2 Months

Secondary Outcomes (18)

• 5-D itch scale

  Change From Baseline in Scale at 2 Months

• Hospital Anxiety and Depression Scale

  Change From Baseline in Scale at 2 Months

• Center for Epidemiologic Studies Short Depression Scale

  Change From Baseline in Scale at 2 Months

• Kidney Disease Quality of Life Scale

  Change From Baseline in Scale at 2 Months

• Urine toxin index

  Change From Baseline in index at 2 Months

Study Arms (2)

AST-120

EXPERIMENTAL

sachet Three times a day. (2g/pack\*3pack/box) 1 month

Drug: AST-120

Control

NO INTERVENTION

No intervention

Interventions

AST-120 DRUG

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.

Also known as: Kremezin

AST-120

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The patient must be able to sign the Informed consent form correctly.
• The patient must be able to communicate with the researchers and understand the details of the study project.
• All the drugs that the patient has taken must be traceable to a prescription.

You may not qualify if:

• A physician has advised the patient not to take AST-120.
• 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.
• The patient suffers from any skin disease not attributable to uremic toxins, including allergic or mycotic dermatitis. (If necessary, visit a dermatologist for diagnosis.)
• 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.
• The patient is pregnant or nurses a baby.
• The formula of the drug for cutaneous pruritus has been changed 2 weeks before the screening.
• The skin has undergone UV irradiation or acupuncture therapy 6 weeks before the screening.
• Excessive alcohol or drug abuse has occurred 12 weeks before the screening.
• The patient has participated in an interventional clinical trial 2 months before the screening.
• 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).
• The patient suffers from digestive tract motility disorder and peptic ulcer disease or esophageal varices.

Sponsors & Collaborators

• Conmed Pharmaceutical & Bio-Medical Corporation: lead
• Tri-Service General Hospital: collaborator
• Tungs' Taichung Metroharbour Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• Kaohsiung Medical University: collaborator
• Taichung Tzu Chi Hospital: collaborator
• Fu Jen Catholic University: collaborator

Study Sites (7)

Kaohsiung Medical University Hospital

Kaohsiung City, 81362, Taiwan

Location

Taipei Tzu Chi Hospital

New Taipei City, 235, Taiwan

Location

Fu Jen Catholic University Hospital

New Taipei City, 24352, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407752, Taiwan

Location

Tungs' Taichung MetroHarbor Hospital

Taichung, 433, Taiwan

Location

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

Chang-Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (5)

• Simonsen E, Komenda P, Lerner B, Askin N, Bohm C, Shaw J, Tangri N, Rigatto C. Treatment of Uremic Pruritus: A Systematic Review. Am J Kidney Dis. 2017 Nov;70(5):638-655. doi: 10.1053/j.ajkd.2017.05.018. Epub 2017 Jul 15.

  PMID: 28720208 BACKGROUND

• Malekmakan L, Tadayon T, Pakfetrat M, Mansourian A, Zareei N. Treatments of uremic pruritus: A systematic review. Dermatol Ther. 2018 Sep;31(5):e12683. doi: 10.1111/dth.12683. Epub 2018 Aug 23.

  PMID: 30141218 BACKGROUND

• Niwa T, Emoto Y, Maeda K, Uehara Y, Yamada N, Shibata M. Oral sorbent suppresses accumulation of albumin-bound indoxyl sulphate in serum of haemodialysis patients. Nephrol Dial Transplant. 1991;6(2):105-9. doi: 10.1093/ndt/6.2.105.

  PMID: 1906999 BACKGROUND

• Liu WC, Tomino Y, Lu KC. Impacts of Indoxyl Sulfate and p-Cresol Sulfate on Chronic Kidney Disease and Mitigating Effects of AST-120. Toxins (Basel). 2018 Sep 11;10(9):367. doi: 10.3390/toxins10090367.

  PMID: 30208594 BACKGROUND

• Sukul N, Speyer E, Tu C, Bieber BA, Li Y, Lopes AA, Asahi K, Mariani L, Laville M, Rayner HC, Stengel B, Robinson BM, Pisoni RL; CKDopps and CKD-REIN investigators. Pruritus and Patient Reported Outcomes in Non-Dialysis CKD. Clin J Am Soc Nephrol. 2019 May 7;14(5):673-681. doi: 10.2215/CJN.09600818. Epub 2019 Apr 11.

  PMID: 30975656 RESULT

MeSH Terms

Interventions

AST 120

Study Officials

• Po-Sung Lin, Dr.

  Tungs' Taichung MeltroHarbor Hospital

  STUDY CHAIR

• Chia-Chao Wu, Dr.

  Tri-Service General Hospital

  STUDY CHAIR

• Shou-Hsuan Liu, Dr.

  Chang Gung Memorial Hospital

  STUDY CHAIR

• Yi-Wen Chiu, Dr.

  Kaohsiung Medical University

  STUDY CHAIR

• Ming-Ju Wu, Dr.

  Taichung Veterans General Hospital

  STUDY CHAIR

• Kuo-Cheng Lu, Dr.

  Taipei Buddhist Tzu Chi Medical Foundation

  PRINCIPAL INVESTIGATOR

• Lin-Kuo Ko, Dr.

  Taichung Tzu Chi Hospital

  STUDY CHAIR

• Jian-Lin Lu, Dr.

  Fu Jen Catholic University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 20, 2020
• Study Start: July 2, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7)