Clinical Trial: Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1/2, Randomised, Placebo-controlled, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of OC5 to Reduce Urinary Oxalate in Subjects With Primary Hypero
Brief Summary: The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
Detailed Summary:
Sponsor: OxThera
Current Primary Outcome: Change in urinary oxalate levels from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ]
Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects defined by:
- baseline urinary oxalate level, above and below 1.5 mmol/24h/1.73m2
- concomitant vitamin B6 therapy and no vitamin B6 therapy
- eGFR of ≥90 mL/min/1.73m2 (normal renal function) and < 90 mL/min/1.73m2 (mild to moderate reduction in renal function)
- age below 18 and age 18 or above
- Number of subjects who reach urinary oxalate levels below 0.5, 0.7 and 1.0 mmol/24h/1.73m2 respectively from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ]
- Change in plasma oxalate levels from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ]
- Change in urinary oxalate levels from Baseline to week 4 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 10 of the study) ]
- Correlation between change in plasma oxalate levels and change in urinary oxalate levels, from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ]
- Change in number of O. formigenes in faeces from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ]
- Adverse events [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ]
- Haematology [ Time Frame: 14 weeks (Throughout the study) ]Blood samples taken for hematology at weeks 0, 5, 10 and 14. Complete blood count with differential and platelet count evaluated.
- Clinical Chemistry [ Time Frame: 14 weeks (Throughout the study) ]Blood samples taken for clinical chemistry at weeks 0, 5, 10 and 14. Blood Urea Nitrogen, creatinine, electrolytes (Na+, K+, Mg++, Ca++, HCO3+, Cl), glucose, pH, albumin, alkaline phosphatase, ALT, AST, total bilirubin and total protein evaluated.
- Urinalysis [ Time Frame: 14 weeks (Throughout the study) ]Urine samples will be taken at weeks 0, 5, 10 and 14 of the study. Protein, glucose and pH evaluated.
Original Secondary Outcome: Same as current
Information By: OxThera
Dates:
Date Received: December 11, 2013
Date Started: December 2013
Date Completion:
Last Updated: October 14, 2015
Last Verified: October 2015