Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00715260
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00715260
Study Brief:
Protocol Section:
NCT00715260