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Phase III

Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

  • Study HIC#:2000024788
  • Last Updated:07/15/2021

Brief Summary:

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria

  • Age18 years and older
  • GenderBoth
  • Start Date06/28/2019
  • End Date07/31/2019

Trial Purpose and Description

Key Objectives Determine the efficacy and durability of effect of reloxaliase in reducing UOx excretion in subjects with enteric HOx Evaluate the long-term safety of reloxaliase Evaluate the long-term effect of treatment with reloxaliase on kidney stone disease progression and kidney function Assess impact of treatment with reloxaliase on burden of illness (kidney stone associated healthcare resource utilization)

Eligibility Criteria

Inclusion Criteria:

  1. Provided informed consent
  2. Age 18 or older
  3. History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
  4. Urinary Oxalate ≥ 50mg/24h

Exclusion Criteria:

  1. Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
  2. Unable or unwilling to discontinue Vitamin C supplementation

Sub-Investigator

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