Does Indoxyl Sulfate Have a Role in Uremic Pruritus?

Sponsor

Benha University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05634083

Collaborator

(none)

Enrollment

Locations

Arm

1.9

Anticipated Duration (Months)

22.5

Patients Per Site

11.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus	Dietary Supplement: Uremic pateints with itching	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients will take activated charcoal for two monthsPatients will take activated charcoal for two months

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jan 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Uremic Pateints group Patients with end-stage renal failure with itching	Dietary Supplement: Uremic pateints with itching Activated charcoal

Arm

Intervention/Treatment

Experimental: Uremic Pateints group

Patients with end-stage renal failure with itching

Dietary Supplement: Uremic pateints with itching

Activated charcoal

Outcome Measures

Primary Outcome Measures

Severity of itching [Two months]
Change of severity of itching by The Visual Analogue Scale score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Benha University	Al Qalyūbīyah	Benha	Egypt
2	Benha University Hospitals	Banhā		Egypt

Sponsors and Collaborators

Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Essam Mohamed El-sayed Akl, Assistant Professor of Dermatology and Andrology, Benha University

ClinicalTrials.gov Identifier:

NCT05634083

Other Study ID Numbers:

RC 22-10-2022

First Posted:

Dec 1, 2022

Last Update Posted:

Dec 1, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pruritus

Study Results

No Results Posted as of Dec 1, 2022