An Observational Study of Pruritus Amongst Hemodialysis Patients

NCT00715260 | Unknown

• 1 other identifier: AC120-8002
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 5

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.

Conditions

Pruritus; Kidney Failure, Chronic; Hemodialysis; Chronic Disease

Study Arms (1)

UP Patients on HD

Uremic Pruritus (UP) patients maintained on hemodialysis (HD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acologix, Inc.: lead

Study Sites (5)

Kidney Care Associates

Augusta, Georgia, 30901, United States

Location

FMC Metaire

Metaire, Louisiana, 70006, United States

Location

Western New England Renal Associates

Springfield, Massachusetts, 01089, United States

Location

Southeast Renal Associates

Charlotte, North Carolina, 28208, United States

Location

Nephrology Associates

Chattanooga, Tennessee, 37404, United States

Location

MeSH Terms

Conditions

Pruritus; Kidney Failure, Chronic; Chronic Disease

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Dawn McGuire, M.D.

  Acologix, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 15, 2008
• Study Start: December 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 15, 2008

Record last verified: 2008-07

Locations

US (5)