NCT00638703

Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, International Study to Evaluate the Efficacy and Safety of OxabactTM to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: OxThera · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

Conditions

• Primary Hyperoxaluria

Interventions

Type	Name	Description
BIOLOGICAL	Oxalobacter formigenes	NLT (not less than) 10\^7 CFU Oxalobacter formigenes twice daily for 24 weeks
DRUG	Placebo	placebo

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-03-19
• Last updated: 2013-05-15

Locations

1 site across 1 country: United States