ePHex: a phase 3, double-blind, placebo-controlled, randomized study to evaluate long-term efficacy and safety of Oxalobacter formigenes in patients with primary hyperoxaluria.
Gema AricetaLaure CollardSaoussen AbrougShabbir H MoochhalaEdward GouldAbir BoussettaMohamed Ben HmidaSudarsana DeTracy E HunleyFaical JarrayaGloria FragaAna BanosElisabeth LindnerBastian DehmelGesa SchalkPublished in: Pediatric nephrology (Berlin, Germany) (2022)
Oxabact treatment may have stabilized/reduced plasma oxalate versus a rise with placebo, but the difference over 12 months was not statistically significant (p = 0.06). A subtle effect observed with Oxabact suggests that O. formigenes may aid in preventing kidney stones. A higher resolution version of the Graphical abstract is available as Supplementary information.