Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria

Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24

Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment

Time frame: 24 weeks

Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4

Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment

Time frame: 4 weeks

Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones

Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo

Time frame: up to 48 months

Change in estimated glomerular filtration rate (eGFR) from baseline

Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo