Back to resultsDoes Indoxyl Sulfate Have a Role in Uremic Pruritus?
Primary Purpose
Pruritus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Uremic pateints with itching
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus
Eligibility Criteria
Inclusion Criteria: Patients with end-stage renal failure with itching undergoing regular hemodialysis Exclusion Criteria: Patients with other causes of itching as psoriasis, atopic dermatitis, scabies, and lichen planus
Sites / Locations
- Faculty of Medicine, Benha University
- Benha University Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Uremic Pateints group
Arm Description
Patients with end-stage renal failure with itching
Outcomes
Primary Outcome Measures
Severity of itching
Change of severity of itching by The Visual Analogue Scale score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05634083
Brief Title
Does Indoxyl Sulfate Have a Role in Uremic Pruritus?
Official Title
Does Indoxyl Sulfate Have a Role in Uremic Pruritus? A Laboratory and Interventional Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Itching is a widespread and disturbing complain from patients with chronic kidney disease (CKD); epidemiologic data have suggested that approximately 40% of patients with end-stage renal disease experience moderate to severe itching. The pathogenesis of renal pruritus is multifactorial. Triggering factors may include uremia-related abnormalities, accumulation of uremic toxins, systemic inflammation and cutaneous xerosis. Indoxyl sulfate (IS) is a protein-bound uremic toxin resulting from the metabolism of dietary tryptophan accumulating in patients with end-stage renal disease.
Detailed Description
Patients with end-stage renal disease undergoing hemodialysis complaining of itching not related to other cause than renal failure will take activated charcoal with foods and serum level of indoxyl sulphate will be studied
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will take activated charcoal for two months
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uremic Pateints group
Arm Type
Experimental
Arm Description
Patients with end-stage renal failure with itching
Intervention Type
Dietary Supplement
Intervention Name(s)
Uremic pateints with itching
Intervention Description
Activated charcoal
Primary Outcome Measure Information:
Title
Severity of itching
Description
Change of severity of itching by The Visual Analogue Scale score
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with end-stage renal failure with itching undergoing regular hemodialysis
Exclusion Criteria:
Patients with other causes of itching as psoriasis, atopic dermatitis, scabies, and lichen planus
Facility Information:
Facility Name
Faculty of Medicine, Benha University
City
Al Qalyūbīyah
State/Province
Benha
Country
Egypt
Facility Name
Benha University Hospitals
City
Banhā
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Indoxyl Sulfate Have a Role in Uremic Pruritus?
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