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A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

Primary Hyperoxaluria Clinical Trial

Official title:
A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

Clinical Trial Summary

This study will evaluate the efficacy and safety of OC5 in patients with PH.

Clinical Trial Description

To evaluate the efficacy of Oxabact following 52 weeks treatment in subjects with maintained kidney function, but below the lower limit of the normal range (estimated glomerular filtration rate [eGFR] < 90 ml/min/1.73 m2) and a total plasma oxalate (Pox) concentration ≥ 10 μmol/L. Parameters to be evaluated include the ability to stabilise/reduce Pox concentration, to stabilise/improve kidney function and to reduce oxalate deposits in primary hyperoxaluria (PH) subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03116685
Study type Interventional
Source OxThera
Contact
Status Completed
Phase Phase 3
Start date January 9, 2018
Completion date April 15, 2021
View Details
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