PruritusNCT05634083
Does Indoxyl Sulfate Have a Role in Uremic Pruritus?
A study testing Uremic pateints with itching in people with Pruritus, run by Benha University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- Uremic pateints with itching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Nov 2022to 22 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with end-stage renal failure with itching undergoing regular hemodialysis
Who cannot join
- Patients with other causes of itching as psoriasis, atopic dermatitis, scabies, and lichen planus
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine, Benha University
Al Qalyūbīyah, Benha
Benha University Hospitals
Banhā
About this study
Official title: 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.
Read the 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
- Conditions
- Pruritus
- Being tested
- Uremic pateints with itching
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uremic pateints with itchingDietary supplement
Activated charcoal
| Study group | Role | What they receive |
|---|---|---|
| Uremic Pateints group | Experimental | Patients with end-stage renal failure with itching Receives: Dietary Supplement: Uremic pateints with itching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of itching
Change of severity of itching by The Visual Analogue Scale score
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start25 Nov 2022
- Primary completion31 Dec 2022
- Study completion22 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will take activated charcoal for two months
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam Mohamed El-sayed Akl, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634083
- Sponsor's protocol ID
- RC 22-10-2022
- Status last verified
- Feb 2023
- First submitted
- 18 Nov 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Indoxyl Sulfate Have a Role in Uremic Pruritus? A Laboratory and Interventional Study.
- ClinicalTrials.gov ID
- NCT05634083
- Acronym / sponsor ID
- RC 22-10-2022
- Conditions
- Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 22 Jan 2023 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will take activated charcoal for two months
| Arm | Type | Receives |
|---|---|---|
| Uremic Pateints group | Experimental | Dietary Supplement: Uremic pateints with itchingPatients with end-stage renal failure with itching |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with end-stage renal failure with itching undergoing regular hemodialysis
Key exclusion criteria (1 listed)
- Patients with other causes of itching as psoriasis, atopic dermatitis, scabies, and lichen planus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uremic pateints with itchingActivated charcoal | Dietary supplement | Uremic Pateints group |
Primary outcome
Severity of itching
Time frame: Two months
Change of severity of itching by The Visual Analogue Scale score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uremic pateints with itching in people with Pruritus, run by Benha University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of itching (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.