NCT02503345

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

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 Hyperoxaluria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Allena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.

Detailed description

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.

Conditions

• Secondary Hyperoxaluria
• Nephrolithiasis
• Kidney Stones
• Hyperoxaluria
• Dietary Hyperoxaluria

Interventions

Type	Name	Description
DRUG	ALLN-177 low dose	ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
DRUG	ALLN-177 mid dose	ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
DRUG	ALLN-177 high dose	ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
DRUG	Placebo	Placebo: 1, 2 or 5 capsules with meals PO 3 times per day

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-08-01
• Completion: 2017-01-01
• First posted: 2015-07-21
• Last updated: 2018-01-11

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study