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:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT05180968
Eligibility Criteria:
Inclusion Criteria:
1. Age\>25 years
2. In-center or home hemodialysis at least two times weekly or peritoneal dialysis at least once daily for \>90 days
3. Generalized uremic pruritus with a mean worst VAS\>40mm over the previous week (with at least 5/7 patient diary days completed)
4. ALT less or equal to 3x upper limit of normal and bilirubin less than or equal to 2x upper limit of normal in the last 90 days
5. Able to provide informed consent and complete patient reported outcome measurements without a language barrier or cognitive impairment
Exclusion Criteria:
1. Etiology of pruritus (in the opinion of the treating physician) thought to be secondary to primary dermatologic condition, liver disease, hematologic malignancy or allergy
2. Use of recreational or medical cannabis in the last 4 weeks (THC, CBD, nabilone, Sativex, Epidiolex)
3. Women of childbearing potential as assessed by their clinician regardless of abstinence from sex or the use of contraception
4. Planned kidney transplantation, travel or relocation in the next 3 months
5. Unstable psychiatric illness (the presence of a lifetime diagnosis of a psychotic disorder, bipolar disorder, substance use disorder or current suicidal ideation)
6. Symptomatic hypotension in the last 2 weeks defined as a systolic blood pressure (SBP) less than 90mmHg during or in between dialysis requiring an intervention (i.e. administration of crystalloid or colloid, termination of dialysis, change in pharmacologic therapy such as withdrawal of anti-hypertensive therapy or initiation/titration of midodrine, increase in dry weight)
7. History of hypersensitivity to any cannabinoid
8. Presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, pulmonary disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT05180968
Study Brief:
Protocol Section:
NCT05180968