This study will evaluate the efficacy and safety of OC5 in patients with PH.
To evaluate the efficacy of Oxabact following 52 weeks treatment in subjects with maintained kidney function, but below the lower limit of the normal range (estimated glomerular filtration rate \[eGFR\] \< 90 ml/min/1.73 m2) and a total plasma oxalate (Pox) concentration ≥ 10 μmol/L. Parameters to be evaluated include the ability to stabilise/reduce Pox concentration, to stabilise/improve kidney function and to reduce oxalate deposits in primary hyperoxaluria (PH) subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Active study drug
Placebo
Vanderbilt University Hospital
Nashville, Tennessee, United States
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Hôpital Robert Debré
Paris, France
Kindernierenzentrum Bonn
Bonn, Germany
Change From Baseline in Plasma Oxalate Concentration After 52 Weeks of Treatment
Change from baseline in total plasma oxalate concentration after 52 weeks of treatment in micromole/liter
Time frame: 52 weeks
Change From Baseline in Kidney Function
Evaluation based on eGFR calculation using the 2009 creatinine-based "Schwartz bedside" equation (for children below 18 years of age) (Schwartz et al., 2009) and 2009 creatinine-based CKD-EPI equation for adults (Levey et al., 2009). Subjects who turn 18 during the study period were continuously evaluated using the Schwartz equation, ie the equation used at baseline was kept throughout the study.
Time frame: 52 weeks
Frequency of Kidney Stone Events
Number of kidney stone events for each patient
Time frame: Through week 48
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Hospital Vall d' Hebron
Barcelona, Spain
Hédi Chaker University Hospital
Sfax, Tunisia
Sahloul University Hospital
Sousse, Tunisia
Charles Nicolle University Hospital
Tunis, Tunisia
Royal Free Hospital
London, United Kingdom
Nottingham Children's Hospital
Nottingham, United Kingdom