Kidney Failure, ChronicNCT01727180
Pruritus in Patients With Chronic Kidney Disease
An observational study of Kidney Failure, Chronic and Pruritus, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
We believe that knowing characteristics of uremic pruritus is the foundation to investigate its pathophysiology and offer better skin care for patients with chronic kidney disease. We therefore conducted this cross-sectional study to evaluate the characteristics of uraemic pruritus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Pruritus
- What is being tested?
- Questionnaire based on the McGill Pain Questionnaire
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD stage 3 to 5D, followed-up in the Far Eastern Memorial Hospital
Who may be able to join
- Adults older than 20 years old, with CKD stage 3 to 5D, with symptoms of pruritus.
Who cannot join
- Patients who refused to answer the questionnaire or unable to understand the contents of the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
We believe that knowing characteristics of uremic pruritus is the foundation to investigate its pathophysiology and offer better skin care for patients with chronic kidney disease. We therefore conducted this cross-sectional study to evaluate the characteristics of uraemic pruritus.
- Conditions
- Kidney Failure, Chronic, Pruritus
- Being tested
- Questionnaire based on the McGill Pain Questionnaire
- Medical subject headings
- Kidney Failure, Chronic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire based on the McGill Pain QuestionnaireOther
Interview questionnaire based on the short form of the McGill Pain Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Not described Receives: Other: Questionnaire based on the McGill Pain Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable
Measured: Once at the entry of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hon-Yen Wu, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727180
- Sponsor's protocol ID
- 100047-E
- Status last verified
- Mar 2015
- First submitted
- 12 Nov 2012
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pruritus in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01727180
- Acronym / sponsor ID
- 100047-E
- Conditions
- Kidney Failure, Chronic, Pruritus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We believe that knowing characteristics of uremic pruritus is the foundation to investigate its pathophysiology and offer better skin care for patients with chronic kidney disease. We therefore conducted this cross-sectional study to evaluate the characteristics of uraemic pruritus.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | Other: Questionnaire based on the McGill Pain Questionnaire |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD stage 3 to 5D, followed-up in the Far Eastern Memorial Hospital
Key inclusion criteria (1 listed)
- Adults older than 20 years old, with CKD stage 3 to 5D, with symptoms of pruritus.
Key exclusion criteria (1 listed)
- Patients who refused to answer the questionnaire or unable to understand the contents of the questionnaire.
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 |
|---|---|---|
| Questionnaire based on the McGill Pain QuestionnaireInterview questionnaire based on the short form of the McGill Pain Questionnaire | Other | Chronic kidney disease |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Once at the entry of the study
A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hon-Yen Wu, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Pruritus, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (VAS) (time frame: Once at the entry of the study). 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 17 Mar 2015.