A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Status Completed

Clinical Trial Summary

Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03095885
Study type	Interventional
Source	Allena Pharmaceuticals
Contact
Status	Completed
Phase	N/A
Start date	November 2016
Completion date	March 2017

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