Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized Double-Blind Placebo-Controlled Study (URIROX-2 )

Brief description of study

This research study is being done to look at how well reloxaliase (ALLN-177) works for the treatment of enteric hyperoxaluria and the decrease of kidney stones, and to understand how safe it is and what side effects may occur. Hyperoxaluria refers to a large amount of oxalate in the urine. Too much oxalate in the urine can lead to build-up of calcium oxalate crystals in the kidneys and urinary tract, which can lead to kidney stones, decreased kidney function, and even kidney failure. In patients with decreased kidney function, oxalate can accumulate in the blood; this can lead to deposits of oxalate in other tissues such as the skin or blood vessels, which can lead to other health problems. Reloxaliase (ALLN-177) is “oxalate decarboxylase”, an enzyme (protein) that breaks down oxalate. This study involves the use of an investigational drug known as reloxaliase (ALLN-177). Reloxaliase (ALLN-177) is being compared to placebo.

Clinical Study Identifier: s19-01501 Identifier: NCT03847090
Principal Investigator: Lama Nazzal.

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