NCT05634083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

November 18, 2022

Last Update Submit

February 6, 2023

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

  • Severity of itching

    Change of severity of itching by The Visual Analogue Scale score

    Two months

Study Arms (1)

Uremic Pateints group

EXPERIMENTAL

Patients with end-stage renal failure with itching

Dietary Supplement: Uremic pateints with itching

Interventions

Uremic pateints with itchingDIETARY_SUPPLEMENT

Activated charcoal

Uremic Pateints group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with end-stage renal failure with itching undergoing regular hemodialysis

You may not qualify if:

  • Patients with other causes of itching as psoriasis, atopic dermatitis, scabies, and lichen planus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine, Benha University

Al Qalyūbīyah, Benha, Egypt

Location

Benha University Hospitals

Banhā, Egypt

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients will take activated charcoal for two months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology and Andrology

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 1, 2022

Study Start

November 25, 2022

Primary Completion

December 31, 2022

Study Completion

January 22, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)