Phase 2
N=10
Oxazyme in Patients With Hyperoxaluria
Hyperoxaluria
Bottom Line
View on ClinicalTrials.gov: NCT01127087 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Urinary Oxalate Creatinine Ratio — 68.6; 38.7; 49.6; 34.7 mg/g — p=0.027
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxazyme (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Oxalate Creatinine Ratio |
68.6; 38.7; 49.6; 34.7 | 0.027 sig |
| SECONDARY Total Urinary Oxalate Excretion |
66.3; 43.2; 44.5; 32.3 | 0.018 sig |
Summary
Hypothesis: Oral administration of the oxalate metabolizing enzyme Oxazyme (OC4) will degrade food-borne oxalate and hence 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 hence oxalate excretion in the urine.
Eligibility Criteria
Inclusion Criteria
- Roux-en-Y gastric bypass hyperoxaluric Calcium oxalate (CaOx) stone subjects or Idiopathic hyperoxaluric CaOx stone subjects
- Patients 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
- The patient must be able to provide written informed consent
- Patients must be able to urinate reliably into a collection vessel to measure urine volume.
- Patients may be taking 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 patients
- Use of Oxadrop, Oxabsorb, or other therapies affecting oxalate absorption from the gut, other than stable doses of calcium.
- Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice some form of birth control during the trial.
- Patients on an unstable dose of any other drugs for the prevention of stone disease (i.e., pyridoxine, citrate supplements. etc.). Patients should have been on a stable dose for at least 3 months prior to randomization.
Data sourced from ClinicalTrials.gov (NCT01127087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.