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About uriROX-1 Study
 

uriROX-1


Allena Pharmaceuticals, Inc. is committed to developing a safe and effective treatment for people with enteric hyperoxaluria.


What is the purpose of the uriROX-1 study?

 

The purpose of the uriROX-1 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.

How is the uriROX-1 study different from the uriROX-2 study? 



   uriROX-1  BOTH   uriROX-2


    • Does not require you to have had a kidney stone in the past 2 years.
    • Expected to last about 12 weeks



Looking for
people with enteric hyperoxaluria 

    • Specifically looking for people that have had a kidney stone(s) in the past 2 years
    • Expected to last a minimum of 2 years and may last up to a maximum of 5 years
    • If you are interested in learning more about uriROX-2, click here


Who can participate in the uriROX-1 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)
  • 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 will be required to complete a 24-hour urine collection to make sure you are eligible for 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 about 12 weeks and will include a 4-week Screening Period, 4-week Treatment Period, and a Follow-Up Visit.

During the treatment period, you can expect the following:
  • Take 2 capsules of reloxaliase or placebo with each meal/snack 3 to 5 times per day for 4 weeks. 
  • Perform two, 24-hour urine collections each week.

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 a capsule             

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 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-1 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. 
 
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