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ABSTRACT: Purpose
To evaluate the potential of ALLN-177, an orally administered, oxalate-specific enzyme therapy to reduce urine oxalate (UOx) excretion in patients with secondary hyperoxaluria.Methods
Sixteen male and female subjects with both hyperoxaluria and a kidney stone history were enrolled in an open-label study. Subjects continued their usual diets and therapies. During a 3-day baseline period, two 24-h (24-h) urines were collected, followed by a 4-day treatment period with ALLN-177 (7,500 units/meal, 3 × day) when three 24-h urines were collected. The primary endpoint was the change in mean 24-h UOx from baseline. Safety assessments and 24-h dietary recalls were performed throughout.Results
The study enrolled 5 subjects with enteric hyperoxaluria and 11 with idiopa
SUBMITTER: Lingeman JE
PROVIDER: S-EPMC6459785 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature