A Study of the Safety and Effectiveness of Oxazyme in Patients with Hyperoxaluria

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of oral administration of the oxalate metabolizing enzyme Oxazyme (OC4) to degrade food-borne oxalate and prevent its absorption from the gastrointestinal tract. In addition, by reducing oxalate concentrations in the gastrointestinal fluid, oxalate secretion from blood to the intestinal tract may be increased. Both effects would decrease blood levels of oxalate, and therefore decrease oxalate excretion in the urine.

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.

This study has been completed

Inclusion Criteria

Roux-en-Y gastric bypass hyperoxaluric Calcium oxalate (CaOx) stone subjects or Idiopathic hyperoxaluric CaOx stone subjects
Must have or had radio-opaque stones present on x-ray, or a history consistent with the passage of a stone, or stone surgery, or Extracorporeal Shock Wave Lithotripsy (ESWL) in the last 5 years
Hyperoxaluria Ox/Cr ratio ≥36 mg/g
Must be able to provide written informed consent
Must be able to urinate reliably into a collection vessel to measure urine volume
May take drugs for the prevention of stone disease, including pyridoxine, thiazides, citrate supplements and allopurinol, as long as there have been no changes in these medications for at least 3 months

Exclusion Criteria

Primary hyperoxaluria
Use of Oxadrop, Oxabsorb, or other therapies affecting oxalate absorption from the gut, other than stable doses of calcium
Pregnancy
A negative pregnancy test prior to enrollment
Must practice some form of birth control during the trial
On an unstable dose of any other drugs for the prevention of stone disease (i.e., pyridoxine, citrate supplements. etc.)
- Should have been on a stable dose for at least 3 months prior to randomization

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
Rochester, Minn. Mayo Clinic principal investigator John Lieske, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

John Lieske, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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