NCT03456830

Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Allena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

Detailed description

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.

Conditions

• Enteric Hyperoxaluria

Interventions

Type	Name	Description
DRUG	ALLN-177	ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days
DRUG	Placebo	Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days

Timeline

• Start date: 2018-05-21
• Primary completion: 2019-09-30
• Completion: 2019-10-28
• First posted: 2018-03-07
• Last updated: 2020-02-27

Locations

63 sites across 7 countries: United States, Canada, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study