NCT01727180

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

November 12, 2012

Results QC Date

March 4, 2015

Last Update Submit

March 4, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Once at the entry of the study

Study Arms (1)

Chronic kidney disease

Other: Questionnaire based on the McGill Pain Questionnaire

Interventions

Interview questionnaire based on the short form of the McGill Pain Questionnaire

Chronic kidney disease

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with CKD stage 3 to 5D, followed-up in the Far Eastern Memorial Hospital

You may qualify if:

  • Adults older than 20 years old, with CKD stage 3 to 5D, with symptoms of pruritus.

You may not qualify if:

  • Patients who refused to answer the questionnaire or unable to understand the contents of the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Kidney Failure, ChronicPruritus

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and Symptoms

Results Point of Contact

Title
Hon-Yen Wu, MD, PHD
Organization
Far Eastern Memorial Hospital

Study Officials

  • Hon-Yen Wu, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 15, 2012

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2013

Last Updated

March 17, 2015

Results First Posted

March 17, 2015

Record last verified: 2015-03

Locations