Clinical Study

Urirox-2 Study For Patients With Kidney Stones And An Underlying Enteric Condition.

Posted Date: Mar 30, 2021

  • Investigator: Shashi Kant
  • Specialties:
  • Type of Study: Drug

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. 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. 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 procedures • 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.

Criteria:

Subjects Must Have Had At Least One Kidney Stone In The Last Two Years. Subjects Also Must Have A Medical Condition That Can Lead To Malabsorption. On Screening, Oxalate In The Urine Must Be >50 Mg In 24 Hours. Kidney Function Must Be Egfr >30. Subject Cannot Have Had Cancer Or Cancer Treatment In The Past 12 Months, Or Have A Cause For Kidney Stones Thought To Be Related To Infection, Genetics, Or Some Medications. Other Criteria Will Apply.

Keywords:

Renal, Oxaluria, Oxalate

For More Information:

Heather J Duncan, Phd
513-559-3362
heather.duncan@uc.edu


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