NCT03847090

Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria

Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (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, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

Detailed description

This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.

Conditions

• Enteric Hyperoxaluria

Interventions

Type	Name	Description
DRUG	Reloxaliase	Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
DRUG	Placebo	Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day

Timeline

• Start date: 2019-08-26
• Primary completion: 2022-05-19
• Completion: 2022-05-19
• First posted: 2019-02-20
• Last updated: 2022-06-10

Locations

113 sites across 16 countries: United States, Austria, Belgium, Brazil, Canada, Croatia, France, Germany, Italy, Mexico, Portugal, Romania, Russia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study