Clinical trial
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis
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.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: May 19, 2014
Actual Primary Completion Date: January 29, 2020
Actual Study Completion Date: January 29, 2020
Arm:
- Experimental: Oxabact OC5 capsule
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 12 |
| Actual Study start date | 19 May 2014 |
| Estimated Study Completion Date | 29 January 2020 |