A Phase 1/2 interventional study of Oxazyme in Hyperoxaluria, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-24.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment
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.
Oxazyme is an oxalate degrading compound that can potentially degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract.
We propose a 20-patient open-label trial pilot study of one month of Oxazyme twice daily (1gm Oxazyme sachet dissolved in 150 ml water) among adult subjects with a history of calcium oxalate nephrolithiasis. Patients will be stratified into those with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB, n=10) and those with idiopathic hyperoxaluria (n=10). The patients will perform two, 24-hour, urine collections immediately before starting Oxazyme and on the last two days of the treatment period.
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Exclusion Criteria:
Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB). Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
Drug: Oxazyme
Subjects with idiopathic hyperoxaluria. Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
Drug: Oxazyme
Oxazyme (registered trademark) is a non-systemic orally delivered drug composed of recombinant oxalate decarboxylase (OxDC). It is formulated to enzymatically degrade available dietary oxalate prior to its absorption. Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
Also known as: oxalate decarboxylase, OC4
Urinary Oxalate Creatinine Ratio
The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.
Time frame: Baseline, Week 4
Total Urinary Oxalate Excretion
Oxalate is a salt of oxalic acid produced by the body's metabolism and excreted in the urine, measured in this study in two, 24-hour, urine collections.
Time frame: Baseline, 4 weeks
Participants were recruited from the Mayo Clinic, Rochester, Minnesota.
| Milestone | RYGB CaOx Stone Formers | Idiopathic Hyperoxaluria CaOx Stone Formers |
|---|---|---|
| Started | 8 | 2 |
| Completed | 8 | 2 |
| Not completed | 0 | 0 |
The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.
| mg/g | RYGB CaOx Stone Formers | Idiopathic Hyperoxaluria CaOx Stone Formers |
|---|---|---|
| Baseline | 68.6 ± 36.4 | 38.7 ± 6.9 |
| Week 4 | 49.6 ± 27.9 | 34.7 ± 6.8 |
Oxalate is a salt of oxalic acid produced by the body's metabolism and excreted in the urine, measured in this study in two, 24-hour, urine collections.
| mg/24 hrs | RYGB CaOx Stone Formers | Idiopathic Hyperoxaluria CaOx Stone Formers |
|---|---|---|
| Baseline | 66.3 ± 28.0 | 43.2 ± 5.9 |
| 4 Weeks | 44.5 ± 23.7 | 32.3 ± 3.2 |
Collected over The subjects were assessed for adverse events at each site visit and phone follow-up visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RYGB CaOx Stone Formers | — | 0/8 (0%) | 0/8 (0%) |
| Idiopathic Hyperoxaluria CaOx Stone Formers | — | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | RYGB CaOx Stone Formers | Idiopathic Hyperoxaluria CaOx Stone Formers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 2 | 8 |
| >=65 years | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | RYGB CaOx Stone Formers | Idiopathic Hyperoxaluria CaOx Stone Formers | Total |
|---|---|---|---|
| Female | 5 | 0 | 5 |
| Male | 3 | 2 | 5 |
| Region of Enrollment(participants) | RYGB CaOx Stone Formers | Idiopathic Hyperoxaluria CaOx Stone Formers | Total |
|---|---|---|---|
| United States | 8 | 2 | 10 |
The record gives a start of May 2010, a primary completion of Sep 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2012, 1 year 3 months after primary completion.
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Hyperoxaluria