An Observational Study of Pruritus Amongst Hemodialysis Patients (ITCH Registry)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Acologix, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Acologix, Inc.
ClinicalTrials.gov Identifier:
NCT00715260
First received: July 8, 2008
Last updated: July 14, 2008
Last verified: July 2008

July 8, 2008
July 14, 2008
December 2007
July 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00715260 on ClinicalTrials.gov Archive Site
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An Observational Study of Pruritus Amongst Hemodialysis Patients
A Multicenter, Prospective, Observational Study of Pruritus Amongst Hemodialysis Patients: The ITCH National Registry

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients on thrice-weekly (or more frequent) maintenance hemodialysis who have Uremic Pruritus

  • Pruritus
  • Kidney Failure, Chronic
  • Hemodialysis
  • Chronic Disease
Not Provided
UP Patients on HD
Uremic Pruritus (UP) patients maintained on hemodialysis (HD)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00715260
AC120-8002
No
Dawn McGuire, M.D. Chief Medical Officer, Acologix, Inc.
Acologix, Inc.
Not Provided
Study Director: Dawn McGuire, M.D. Acologix, Inc.
Acologix, Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP