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