NCT03095885

A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Allena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

This was a prospective 4-day study of oxalate absorption in subjects with secondary hyperoxaluria. Subjects visited the research center three times for outpatient visits (Screening, Test Day 3, Day 4). Subjects were instructed to follow a low-oxalate diet, consuming only study-specified food choices that had low or no oxalate and controlled calcium content Days 1 through 4 (Baseline Period through the Day 4 clinic visit) and, on Test Day 3, consumed an oxalate-rich test meal. Subjects performed three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 included the oxalate-rich test meal and the subject collected a 24-hour urine separated into 4 urine collection intervals. (Pre-test meal, post-test meal to 4 hours, 4-6 hours post test meal and remaining time to complete 24 hours).

Conditions

• Secondary Hyperoxaluria
• Nephrolithiasis
• Hyperoxaluria
• Kidney Stones

Interventions

Type	Name	Description
OTHER	Test Meal

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2017-03-30
• Last updated: 2021-10-28
• Results posted: 2020-03-24

Locations

5 sites across 1 country: United States