Clinical Trial: A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
Brief Summary: Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.
Detailed Summary:
This is a prospective uncontrolled study in subjects with secondary hyperoxaluria. Subjects will visit the research center three times for outpatient visits (Screening, Test Day 3, Day 4).
Subjects will perform three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 includes the oxalate-rich test meal and the subject will collect a 24-hour urine separated into 4 urine collection intervals that are timed in relation to the oxalate-rich test meal (Pre-test meal, 4-hr and 6-hr post test meal and remaining time to 24-hours).
Sponsor: Allena Pharmaceuticals
Current Primary Outcome: Percent oxalate absorption from oxalate-rich test meal, urinary oxalate (mg/24-hour) [ Time Frame: 24-hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percent oxalate absorption 4-hours, 6-hours post oxalate-rich test meal and 24-hour. (mg/interval) [ Time Frame: 24-hours ]
- Percent change from baseline urinary oxalate (mg) for each collection interval. [ Time Frame: 24-hours ]
Original Secondary Outcome: Same as current
Information By: Allena Pharmaceuticals
Dates:
Date Received: March 20, 2017
Date Started: November 2016
Date Completion:
Last Updated: March 24, 2017
Last Verified: March 2017
