An Observational Study of Pruritus Amongst Hemodialysis Patients

Chronic Disease Clinical Trial

— ITCH Registry  

Official title:

A Multicenter, Prospective, Observational Study of Pruritus Amongst Hemodialysis Patients: The ITCH National Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00715260
• Other study ID #: AC120-8002
• Status: Active, not recruiting
• Phase: N/A
• First received: July 8, 2008
• Last updated: July 14, 2008
• Start date: December 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Acologix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to better understand the natural history/natural course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During the lifetime of a CKD dialysis patient, UP tends to be a prolonged, frequent, and an intense itch that is known to impair the patient's quality of life (QoL), including sleep and mood.

The study will follow hemodialysis (HD) patients longitudinally to characterize their pruritus over time. The study will quantify and characterize UP and assess change over time; collect data on conditions that may be affected by UP such as sleep, mood, socialization and overall quality of life; collect data on use of medications, particularly anti-pruritic treatments, sleep aids, and medications for depression and anxiety; and collect data on medical resource use, particularly hospitalizations for treatment of skin and other infections over the duration of the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years;

• Patients receiving chronic hemodialysis 3 or more times per week;

• Patients who have "mild", "moderate" or "severe" pruritus;

• "Mild" pruritus is defined as a nighttime or daytime worst itch intensity VAS >10 mm and < 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of < 2;

• "Moderate" pruritus is defined as a nighttime or daytime worst itch intensity VAS >10 mm and < 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of = 3;

• "Severe" pruritus is defined as a nighttime or daytime worst itch intensity VAS of = 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of = 3;

• Patients who are able to understand and complete questionnaires written in English;

• Patients who are expected to continue to dialyze at the present dialysis unit for the duration of the study.

Exclusion Criteria:

• Patients who have pruritus attributed to causes other than chronic kidney disease (CKD) or the direct consequences of CKD (i.e., hyperparathyroidism, circulating "uremic toxins");

• Patients who have had significant alteration in their dialysis regimen within the 2 weeks prior to Screening (or those for whom such changes are anticipated during the study) are excluded. A "significant alteration" is defined as:

• A change in the type of hemodialysis filter;

• An increase or decrease in total duration of dialysis prescribed of > 1 hour/week;

• A change in the site or type of venous access for dialysis;

• An increase or decrease in prescribed blood flow of >100 mL/min;

• Patients who are unwilling to comply with the study protocol. Test Product, Dose, Mode of Administration and Duration of Treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Hemodialysis
• Kidney Failure, Chronic
• Pruritus
• Renal Insufficiency

Locations

Country	Name	City	State
United States	Kidney Care Associates	Augusta	Georgia
United States	Southeast Renal Associates	Charlotte	North Carolina
United States	Nephrology Associates	Chattanooga	Tennessee
United States	FMC Metaire	Metaire	Louisiana
United States	Western New England Renal Associates	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Acologix, Inc.

Country where clinical trial is conducted

United States,