Clinical Trial: Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for up to 60 subjects.

Sponsor: Allena Pharmaceuticals

Current Primary Outcome: Mean urinary oxalate excretion (mg/24 h) following treatment [ Time Frame: on 7 days of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline in mean urinary oxalate excretion (mg/24 h) [ Time Frame: on 7 days of treatment ]

Original Secondary Outcome: Same as current

Information By: Allena Pharmaceuticals

Dates:
Date Received: July 17, 2015
Date Started: July 2015
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017