Allena Pharmaceuticals, Inc is committed to providing safe and effective treatments for patients with rare and severe metabolic and kidney disorders, including enteric hyperoxaluria.
What is the purpose of the uriROX-2 study?
The purpose of the uriROX-2 study is to learn more about the effects of the investigational drug, reloxaliase (also known as ALLN-177), on reducing the levels of oxalate in the urine compared to placebo (no active ingredients) in patients with enteric hyperoxaluria who have had a kidney stone in the past 2 years.
Who can participate in the uriROX-2 study?
You may be able to participate in this study if*:
- You are 18 years of age or older
- You have an underlying gastrointestinal condition associated with malabsorption. Examples:
- Bariatric surgery (surgery for weight loss) at least 12 months ago
- Short bowel syndrome
- Pancreatic insufficiency (can occur with cystic fibrosis and other diseases of the pancreas)
- Inflammatory bowel disease, such as Crohn’s disease or colitis
- Other conditions, such as celiac disease
- You have hyperoxaluria (you have had kidney stones or kidney damage thought to be associated with your underlying gastrointestinal disorder)
- You have had a documented kidney stone within the last 2 years
- You are willing to complete multiple, 24-hour urine collections throughout the study
*Other criteria will apply.
What will happen during the study?
If you are eligible and decide to join the
study, your participation will last between 2 and 5 years. This includes an approximately 3-month screening period, a treatment period of at least 24 months
(2 years), and a 1-month follow-up period. During the treatment period, you can
expect the following:
- Take 2 capsules of study drug with each meal/snack 3 to 5 times per
day and complete a daily diary to record the doses taken
- Complete 24-hour urine collections as well as other assessments and
- Complete imaging visits
(x-ray, ultrasound, and CT, or CT only) to monitor kidney stones
The study staff will monitor your health throughout the entire study.
What is the study drug?
- Reloxaliase is an investigational drug containing oxalate decarboxylase, an enzyme (protein) that breaks down oxalate.
- Placebo looks the same as reloxaliase but does not have the active ingredient.
- Reloxaliase and placebo are provided as capsules
taken by mouth, whole.
What is an investigational drug?
“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.
How does reloxaliase work?
Reloxaliase 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.
Have other people used reloxaliase?
Yes, other people have taken reloxaliase (previously called ALLN-177) in Phase 1 and 2 clinical studies. Overall, reloxaliase was safe and generally well-tolerated.
The uriROX-2 study will look more at the safety and effectiveness of reloxaliase in reducing the levels of oxalate in the urine in patients with enteric hyperoxaluria.