Does Indoxyl Sulfate Have a Role in Uremic Pruritus?

Does Indoxyl Sulfate Have a Role in Uremic Pruritus? A Laboratory and Interventional Study.

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.

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Dietary supplement: Uremic pateints with itching

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banhā, Egypt
    • Benha University Hospitals
  • Benha
    • Al Qalyūbīyah, Benha, Egypt
      • Faculty of Medicine, Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Uremic Pateints group; Patients with end-stage renal failure with itching	Dietary supplement: Uremic pateints with itching; Activated charcoal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of itching	Change of severity of itching by The Visual Analogue Scale score	Two months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2022
• Primary Completion (ACTUAL): December 31, 2022
• Study Completion (ACTUAL): January 22, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (ACTUAL): December 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: RC 22-10-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No