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Oxabact in Primary Hyperoxaluria on Dialysis
NCT02000219Phase 2
Key facts
- Status
- Completed
- Start
- May 2014
- Primary completion
- Jan 2020
- Countries
- 1
- Sponsor
- OxThera AB
- Modality
- Live Biotherapeutic Products
- Conditions
- Primary hyperoxaluria (PH)
01
Overview
Phase 2, open-label, single-arm trial of oxalobacter formigenes in Primary hyperoxaluria (PH), sponsored by OxThera AB. Primary endpoint: Change in Pre Dialysis Plasma Oxalate (Total Plasma Oxalate) Level During Treatment With OC5 Compared With Baseline at 3 years. Started May 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Oxabact OC5 capsule
Oxalobacter formigenes enteric-coated capsules twice daily
03
Who it enrols
Patients >= 2 years old with Primary Hyperoxaluria on stable dialysis with elevated plasma oxalate, excluding those on antibiotics or immunosuppressives.
04
Endpoints
Primary
Change in Pre Dialysis Plasma Oxalate (Total Plasma Oxalate) Level During Treatment With OC5 Compared With Baseline
Secondary
Change in Pre Dialysis Plasma Oxalate (Free Plasma Oxalate) Level During Study Compared With Baseline
Change in Left Ventricular Ejection Fraction From Baseline
Speckle Tracking Echocardiography
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