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
  Purpose

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.


Condition
Pruritus
Kidney Failure, Chronic
Hemodialysis
Chronic Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Observational Study of Pruritus Amongst Hemodialysis Patients: The ITCH National Registry

Resource links provided by NLM:


Further study details as provided by Acologix, Inc.:

Estimated Enrollment: 80
Study Start Date: December 2007
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
UP Patients on HD
Uremic Pruritus (UP) patients maintained on hemodialysis (HD)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715260

Locations
United States, Georgia
Kidney Care Associates
Augusta, Georgia, United States, 30901
United States, Louisiana
FMC Metaire
Metaire, Louisiana, United States, 70006
United States, Massachusetts
Western New England Renal Associates
Springfield, Massachusetts, United States, 01089
United States, North Carolina
Southeast Renal Associates
Charlotte, North Carolina, United States, 28208
United States, Tennessee
Nephrology Associates
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Acologix, Inc.
Investigators
Study Director: Dawn McGuire, M.D. Acologix, Inc.
  More Information

No publications provided

Responsible Party: Dawn McGuire, M.D. Chief Medical Officer, Acologix, Inc.
ClinicalTrials.gov Identifier: NCT00715260     History of Changes
Other Study ID Numbers: AC120-8002
Study First Received: July 8, 2008
Last Updated: July 14, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Disease
Kidney Failure, Chronic
Pruritus
Renal Insufficiency
Disease Attributes
Pathologic Processes
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014