Trials / Completed
CompletedNCT02000219
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis
A Phase 2 Open-label Multi-centre Study to Evaluate the Efficacy and Safety of Oxabact® to Reduce Plasma Oxalate in Subjects With Primary Hyperoxaluria Who Are on Dialysis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- OxThera · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Oxalobacter formigenes | The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner. |
Timeline
- Start date
- 2014-05-19
- Primary completion
- 2020-01-29
- Completion
- 2020-01-29
- First posted
- 2013-12-04
- Last updated
- 2022-01-10
- Results posted
- 2021-12-09
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02000219. Inclusion in this directory is not an endorsement.