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Phase 2/3 Oxabact Study
NCT01037231 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Oxalobacter formigenes
Study Locations (3)
Other
- University Children's Hospital (Division of Pediatric Nephrology) — Cologne
- Academy Medical Center, University of Amsterdam — Amsterdam
Minnesota
- Mayo Clinic (Department of Pediatric Nephrology) — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01037231
The ClinicalTrials.gov registry entry for NCT01037231 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OxThera, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Hyperoxaluria appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01037231 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Other, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01037231 about?
NCT01037231 is a clinical study titled "Phase 2/3 Oxabact Study". The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
What is the current status of trial NCT01037231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2009-12. Estimated completion is 2011-01.
What conditions does trial NCT01037231 study?
This clinical trial studies the following conditions: Primary Hyperoxaluria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01037231?
The interventions under investigation include: Placebo (DRUG), Oxalobacter formigenes (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01037231?
This trial is sponsored by OxThera, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01037231 being conducted?
This trial has 3 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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