NCT01127087 is a Phase 1/Phase 2 clinical trial of Oxazyme in Hyperoxaluria, sponsored by Mayo Clinic.

Who is sponsoring NCT01127087?

NCT01127087 is sponsored by Mayo Clinic.

What drugs are being tested in NCT01127087?

Interventions in NCT01127087: Oxazyme.

What condition does NCT01127087 study?

NCT01127087 studies Hyperoxaluria.

Is NCT01127087 still recruiting?

NCT01127087 is currently completed. Last updated 21 November 2012.

Are results published for NCT01127087?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-11-21 · How we verify

NCT01127087

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Pilot Study to Evaluate the Safety and Efficacy of Oxazyme (OC4) in Patients With Hyperoxaluria

Completed Phase 1/Phase 2 Results posted Last updated 21 November 2012

What this trial tests

Phase 1/Phase 2 trial testing Oxazyme in Hyperoxaluria in 22 participants. Completed in 1 October 2011.

Timeline

1 May 2010

Primary endpoint
1 September 2011

1 October 2011

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	1 May 2010
Primary completion	1 September 2011
Estimated completion	1 October 2011
Sites	1 location across United States

Drugs / interventions tested

Oxazyme — full drug profile →

Conditions studied

Hyperoxaluria — all drugs for Hyperoxaluria →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Hyperoxaluria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Urinary Oxalate Creatinine Ratio
Time frame: Baseline, Week 4
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.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Perspectives in primary hyperoxaluria - historical, current and future clinical interventions.
Shee K, Stoller ML. · · 2022 · cited 41× · PMID 34880452 · DOI 10.1038/s41585-021-00543-4
Antioxidant and Cytotoxic Effects and Identification of <i>Ophiocordyceps sinensis</i> Bioactive Proteins Using Shotgun Proteomic Analysis.
Kong BH, Yap CA, Razif MFM, Ng ST, et al · · 2021 · cited 10× · PMID 34316281 · DOI 10.17113/ftb.59.02.21.7151
Navigating the Evolving Landscape of Primary Hyperoxaluria: Traditional Management Defied by the Rise of Novel Molecular Drugs.
Huang Y, Zhu W, Zhou J, Huang Q, et al · · 2024 · cited 1× · PMID 38785918 · DOI 10.3390/biom14050511

Verify or expand the search:

Other Mayo Clinic trials

Trials by the same sponsor.

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NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01127087 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 21 November 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01127087.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing