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Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis

NCT02000219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-01-10

Study results available
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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

  • Primary Hyperoxaluria

Interventions

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.

Sponsors & Collaborators

  • FP7-SME-2013 Research for the benefit of SMEs program

    collaborator UNKNOWN

  • OxThera

    lead INDUSTRY

Principal Investigators

  • Gesa Schalk, M.D. · University of Bonn

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-19
Primary Completion
2020-01-29
Completion
2020-01-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000219 on ClinicalTrials.gov