Clinical Trial: Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

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

Official Title: A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Recurrent Calcium Oxalate Kidney Stone Formers

Brief Summary: The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

Detailed Summary: A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.
Sponsor: Allena Pharmaceuticals

Current Primary Outcome: Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion [ Time Frame: 7 days ]

Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).


Original Primary Outcome: Change in 24 hour urinary oxalate excretion [ Time Frame: 7 days ]

Change in 24 hour urinary oxalate excretion from baseline


Current Secondary Outcome: Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion [ Time Frame: 7 days ]

Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%


Original Secondary Outcome: Percent change in 24 hour urinary oxalate [ Time Frame: 7 days ]

Percent change in 24 hour urinary oxalate excretion from baseline.


Information By: Allena Pharmaceuticals

Dates:
Date Received: November 10, 2014
Date Started: September 2014
Date Completion:
Last Updated: March 25, 2016
Last Verified: February 2016