Establishing the Safety and Effectiveness of Reloxaliase in Patients With Enteric Hyperoxaluria


About this study

The purpose of this study is to determine the effectiveness, durability, and long-term safety of Reloxaliase in patients with Enteric Hyperoxaluria.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Provided informed consent.
  • Age 18 years or older.
  • Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy).
  • Urinary oxalate ≥ 50 mg/24 hr.
  • Has at least 1 documented kidney stone within 2 years.

Exclusion Criteria:

  • Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2.
  • Has a known genetic, congenital, or other cause of kidney stones.
  • Unable or unwilling to discontinue Vitamin C supplementation.
  • Cannot establish baseline kidney stone burden.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Ivan Porter, M.D.

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

John Lieske, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mira Keddis, M.D.

Closed for enrollment

More information


  • To evaluate the potential of ALLN-177, an orally administered, oxalate-specific enzyme therapy to reduce urine oxalate (UOx) excretion in patients with secondary hyperoxaluria. Read More on PubMed
  • Hyperoxaluria may result from increased endogenous production or overabsorption of dietary oxalate in the gastrointestinal tract leading to nephrolithiasis and, in some, to oxalate nephropathy and chronic kidney disease. ALLN-177 is an oral formulation of a recombinant, oxalate specific, microbial enzyme oxalate decarboxylase intended to treat secondary hyperoxaluria by degrading dietary oxalate in the gastrointestinal tract, thereby reducing its absorption and subsequent excretion in the urine. Read More on PubMed

Additional contact information

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