Oxazyme in Patients With Hyperoxaluria

NCT01127087 | Completed Phase 1 Results

• 1 other identifier: 10-000676
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperoxaluria

Keywords

Hyperoxaluria; Oxazyme; oxalate; enteric hyperoxaluria

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4

Secondary Outcomes (1)

• Total Urinary Oxalate Excretion

  Baseline, 4 weeks

Study Arms (2)

RYGB CaOx Stone Formers

EXPERIMENTAL

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

Idiopathic Hyperoxaluria CaOx Stone Formers

EXPERIMENTAL

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

Interventions

Oxazyme DRUG

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

Idiopathic Hyperoxaluria CaOx Stone Formers; RYGB CaOx Stone Formers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• OxThera: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hyperoxaluria

Interventions

oxalate decarboxylase

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. John C. Lieske
• Organization: Mayo Clinic

lieske.john@mayo.edu

507-266-7960

Study Officials

• John Lieske, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 20, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 24, 2012
• Results First Posted: December 24, 2012

Record last verified: 2012-11

Locations

US (1)