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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT02538016
Eligibility Criteria:
Inclusion Criteria:
* Males and females age 12 - 29 years
* Weight ≥ 25kg (55 lbs)
* Confirmed cystinuria diagnosis
* Specific blood test levels (done within the past 6 months)
Exclusion Criteria:
* Concurrent non-renal disease that might increase risk of complications due to aquaresis
* Liver or biliary disease (chronic or acute)
* Malabsorption syndrome or other gastrointestinal condition that may interfere with response to therapy
* Non-cutaneous malignancy within last 5 years
* History of adverse reaction or allergy to Tolvaptan or other arginine vasopressin V2-receptor antagonists
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
29 Years
Study:
NCT02538016
Study Brief:
Protocol Section:
NCT02538016