The uriROX-02 Study is evaluating an investigational drug designed to potentially help treat and pre These clumps of waste are called kidney stones.
xcess of certain wastes (such as mineral and salt deposits) and not enough fluid in the blood, these wastes can build up and stick together in the kidneys. The most common type of kidney stones are calcium stones, which are caused by a substance called calcium oxalate. For some people, these type of stones are caused by a condition called enteric hyperoxaluria. Hyperoxaluria is a condition in which there are high levels of oxalate in the urine. People with hyperoxaluria are at an increased risk for kidney stones or other kidney damage. Oxalate is found naturally in foods like spinach, nuts, chocolate, and tea. It is also a normal byproduct of metabolism. Normally, it is removed through the stool. However, if you have hyperoxaluria, the excess oxalate is normally removed by the kidneys through your urine. When there is too much oxalate in your urine, it can form crystals. These crystals may cause inflammation or grow into kidney stones. Enteric hyperoxaluria occurs in people with an underlying gastrointestinal condition that leads to absorption of too much oxalate from foods. Examples of these conditions include: Crohn’s disease and other inflammatory bowel diseases or disorders of the pancreas due to cystic fibrosis or pancreatitis. You can also develop enteric hyperoxaluria after certain gastric bypass surgeries or surgery to remove a section of the intestine. What is the investigational drug? The investigational drug (reloxaliase) is a capsule that is taken by mouth and works 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. Investigational drugs can be used only for research purposes. Who can participate? You may be able to participate in this study if you are:
• 18 years of age or older
• You have an underlying gastrointestinal condition, such as:
o Bariatric surgery (surgery for weight loss) at least 12 months ago
o Short bowel syndrome
o Pancreatic insufficiency (can occur with cystic fibrosis and other diseases of the pancreas)
o Inflammatory bowel disease, such as Crohn's disease or colitis
o Celiac disease
• You have had a documented kidney stone within the last 2 years
All eligible study participants will receive at no cost:
• Study-related lab tests and physical exams
• Study drugs
• Compensation for time and travel
To receive more information about this study, or if you or someone you know may be eligible, visit www.uriroxstudies.com. To review Facebook’s Community Standards, please visit the following webpage: https://www.facebook.com/communitystandards
