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
28
The dose will be not less than (NLT) 1E+09 colony forming units (CFU) twice daily for 8 to 10 weeks. The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner.
An enteric-coated placebo capsule manufactured to mimic the OC5 capsule. The capsule will be administered orally with breakfast and dinner twice daily for 8 to 10 weeks.
Hôpital Robert-Debré, Néphrologie Pédiatrique
Paris, Cedex 19, France
Hôpital des Enfants, Centre de référence maladies rénales rares du Sud-Ouest (SORARE), CHU de Bordeaux
Bordeaux, France
Hôpital Femme Mère Enfant, Lyon - Paediatric Dept
Lyon, France
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 urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects
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
Time frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Necker-Enfants Malades,Centre de référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte (MARHEA)
Paris, France
Universitätsklinikum Bonn, Dept of Paediatric Nephrology
Bonn, Germany
Birmingham Children's Hospital NHS Foundation Trust - Dept of Nephrology
Birmingham, United Kingdom
Royal Free Hospital -UCL Centre for Nephrology
London, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, United Kingdom
Adverse events
Time frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
Haematology
Blood samples taken for hematology at weeks 0, 5, 10 and 14. Complete blood count with differential and platelet count evaluated.
Time frame: 14 weeks (Throughout the study)
Clinical Chemistry
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.
Time frame: 14 weeks (Throughout the study)
Urinalysis
Urine samples will be taken at weeks 0, 5, 10 and 14 of the study. Protein, glucose and pH evaluated.
Time frame: 14 weeks (Throughout the study)