Clinical Trial: Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Same as current
Current Secondary Outcome:
- Percentage of subjects who are responders at Week 24 where response is defined as a 20% or greater reduction from Baseline urinary oxalate to Week 24 [ Time Frame: 24 weeks ]
- Percentage change in urinary oxalate (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 [ Time Frame: 24 weeks ]
- Percentage change in urinary oxalate (expressed as mmole/1.73m2/day and as molar oxalate to creatinine ratio) from Baseline to Week 12 [ Time Frame: 12 weeks ]
- Percentage change in urinary oxalate (expressed as mmole/1.73m2/day and as molar oxalate to creatinine ratio) from Baseline to average of Weeks 12 and 24 [ Time Frame: 12 and 24 weeks ]
- Frequency of AEs and SAEs [ Time Frame: over 24 weeks ]
- Laborator safety data [ Time Frame: 12 and 24 weeks ]
Original Secondary Outcome: Same as current
Information By: OxThera
Dates:
Date Received: March 12, 2008
Date Started: October 2007
Date Completion:
Last Updated: May 7, 2013
Last Verified: June 2011
