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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT03346369
Eligibility Criteria:
Inclusion Criteria:
* able to give written informed consenct
* hyperoxaluria (defined as urinary oxalate \> 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit
* history of nephrolithiasis eGFR \> 60 mL/min/1.73m² (CKD-EPI formula)
Exclusion Criteria:
* primary hyperoxaluria, diagnosed by genetic testing
* known allergy to Lanthanum Carbonate
* hypophosphatemia (defined as serum phosphorus \< 0.81 mmol/L)
* severe known liver insufficiency of biliary obstruction
* rectocolitis ulcerohaemorraghica, Crohn's disease, bowel obstruction, stomach/duodenal ulceration
* glucose/galactose malabsorption
* severe diarrhea or other gastrointestinal disorder, which might interfere with the ability to absorb oral medication
* pregnancy or breast-feeding
* female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study
* female participant without negative serum or urine pregnancy test
* psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study
* currently participating in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03346369
Study Brief:
Protocol Section:
NCT03346369