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NCT01037231 · ClinicalTrials.gov registry record · Phase 2

Phase 2/3 Oxabact Study

A Phase 2 study of Primary Hyperoxaluria, sponsored by OxThera.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
3
Study locations

NCT01037231: Completed Phase 2 study of Primary Hyperoxaluria, sponsored by OxThera.

NCT01037231 is a Phase 2 study of Primary Hyperoxaluria that has completed, run by OxThera. The registered enrollment target is 36 participants, below the 1,211-participant average among 3 other Primary Hyperoxaluria trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01037231, a Phase 2 study of Primary Hyperoxaluria, has completed, sponsored by OxThera.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
3
Study locations

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

FieldValue
Enrollment Target 36 participants
Start Date 2009-12
Est. Completion 2011-01
Phase Phase 2
OxThera

4 total trials

What the finished NCT01037231 record still lists

NCT01037231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,211-participant average among 3 other Primary Hyperoxaluria trials with a reported enrollment target (97% lower).

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.

NCT01037231 reports a single indexed study location in Other, Minnesota.

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.

What interventions are being tested in trial NCT01037231?

The interventions under investigation include: Placebo (DRUG), Oxalobacter formigenes (BIOLOGICAL).

Who is sponsoring clinical trial NCT01037231?

This trial is sponsored by OxThera, which has 4 total clinical trials registered on ClinicalTrials.gov.

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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Source: ClinicalTrials.gov NCT01037231, the US trial registry maintained by the National Library of Medicine. NCT01037231 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.