The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
NLT (not less than) 10\^7 CFU oxalobacter formigenes twice daily for 24 weeks
placebo
Mayo Clinic (Department of Pediatric Nephrology)
Rochester, Minnesota, United States
University Children's Hospital (Division of Pediatric Nephrology)
Cologne, Germany
Academy Medical Center, University of Amsterdam
Amsterdam, Netherlands
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24
Time frame: 24 weeks
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 8
Time frame: 8 weeks
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by baseline urinary oxalate level, above and below median at screening
Time frame: 24 weeks
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by concomitant vitamin B6 therapy and no vitamin B6 therapy, in PH type I
Time frame: 24 weeks
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by eGFR of ≥90 mL/min/1.73m2 and < 90 mL/min/1.73m2
Time frame: 24 weeks
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by PH Type I and PH Type II
Time frame: 24 weeks
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by age below 18 and age 18 or above
Time frame: 24 weeks
Percentage of subjects who have ≥20% reduction from Baseline urinary oxalate at Week 24
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage change in plasma oxalate levels
Time frame: 24 weeks
Frequency of Stone Events (i.e. nephrolithiasis or markers thereof)
Time frame: 24 weeks
Correlation between percentage change in plasma oxalate levels and percentage change in urinary oxalate levels, from Baseline to Week 24
Time frame: 24 weeks
Adverse events (AEs), hematology, clinical chemistry, urinalysis.
Time frame: 24 weeks