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