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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT03391804
Eligibility Criteria:
Inclusion Criteria:
1. Signed a informed consent form or an assent
2. Aged 12 or older with body weight ≥ 35kg
3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
4. Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR \>15 mL/min/1.73m2
5. In patients with enteric hyperoxaluria, eGFR \< 45mL/min/1.73m2 at Screening
6. In patients with enteric hyperoxaluria, plasma oxalate \> 5µmol/L at Screening
7. Patients on dialysis, must be stable for greater than 3 months
Exclusion Criteria:
1\. Unable or unwilling to discontinue Vitamin C supplementation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03391804
Study Brief:
Protocol Section:
NCT03391804