Background

About the uriROX‑2 Study

The uriROX‑2 Study is an opportunity to potentially learn what may be causing your kidney stones, and discover a potential way to help prevent them from returning.

Study participation overview

If you are eligible and decide to join the study, your participation will last between two and five years. This includes an approximately three-month screening period, a study treatment period of at least 24 months (two years), and a one-month follow-up period.

During the study treatment period, you will attend regularly scheduled study visits and complete study-related activities and procedures, including:

Health and wellness tests and assessments

Blood and urine samples

Imaging visits (x-ray, ultrasound , and CT, or CT only) to monitor kidney stones

Taking the study drug as directed

Completing a daily study diary

 

Background

uriROX-2

What is the investigational drug?

The investigational drug (reloxaliase) is a capsule that is taken by mouth and may work in the stomach and intestine to break down oxalate in food so that less oxalate is absorbed into the bloodstream. With less oxalate absorbed, less is passed through the kidneys into the urine.

Lowering oxalate levels in the urine may decrease the risk of complications of hyperoxaluria, including kidney stones. “Investigational” means that a drug has not been approved by the US Food and Drug Administration or another regulatory authority for treating patients with this condition. Investigational drugs can be used only for research purposes.

Have other people used reloxaliase?

Yes, other people have taken reloxaliase in Phase one and two clinical studies, and overall, reloxaliase was safe and generally well-tolerated. The uriROX‑2 study will look more at the safety and effectiveness of reloxaliase to see if reducing oxalate may help prevent kidney stones from returning.

Clinical Studies