Clinical trial NCT00715260: An Observational Study of Pruritus Amongst Hemodialysis Patients
Official title: A Multicenter, Prospective, Observational Study of Pruritus Amongst Hemodialysis Patients: The ITCH National Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pruritus
Kidney Failure, Chronic
Hemodialysis
Chronic Disease
Lead sponsor: Acologix, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on thrice-weekly (or more frequent) maintenance hemodialysis who have Uremic Pruritus

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Kidney Care Associates
state: Georgia
city: Metaire
country: United States
facility: FMC Metaire
state: Louisiana
city: Springfield
country: United States
facility: Western New England Renal Associates
state: Massachusetts
city: Charlotte
country: United States
facility: Southeast Renal Associates
state: North Carolina
city: Chattanooga
country: United States
facility: Nephrology Associates
state: Tennessee
Study officials:
affiliation: Acologix, Inc.
name: Dawn McGuire, M.D.
role: STUDY_DIRECTOR
References: