CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Oxalobacter formigenesbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02000219
NCT02000219Phase 2Completed
CompareCT.gov

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

OxThera·interventional·Posted Dec 4, 2013·Updated Jan 10, 2022

In Brief

A Phase 2 clinical trial evaluating Oxalobacter formigenes for Primary Hyperoxaluria. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hyperoxaluria
CountriesGermany
CollaboratorsFP7-SME-2013 Research for the benefit of SMEs program

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 4, 2013
Enrollment StartMay 19, 2014
Primary CompletionJan 29, 2020
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 12.6 years ago

Interventions

Oxalobacter formigenesbiological

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.