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

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.

Study Overview

• Status: Unknown
• Conditions: Hemodialysis; Kidney Failure, Chronic; Chronic Disease; Pruritus

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Kidney Care Associates
  • Louisiana
    • Metaire, Louisiana, United States, 70006
      • FMC Metaire
  • Massachusetts
    • Springfield, Massachusetts, United States, 01089
      • Western New England Renal Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Southeast Renal Associates
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Nephrology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
UP Patients on HD; Uremic Pruritus (UP) patients maintained on hemodialysis (HD)

Collaborators and Investigators

• Sponsor: Acologix, Inc.
• Investigators: Study Director: Dawn McGuire, M.D., Acologix, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Anticipated): July 1, 2008
• Study Completion (Anticipated): July 1, 2008

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): July 15, 2008
• Last Update Submitted That Met QC Criteria: July 14, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Skin Manifestations; Kidney Failure, Chronic; Renal Insufficiency; Chronic Disease; Pruritus
• Other Study ID Numbers: AC120-8002