Clinical Trial: Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Dia
Brief 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.
Detailed Summary:
Sponsor: OxThera
Current Primary Outcome: Change in pre dialysis plasma oxalate level after 6 weeks of treatment, compared with baseline. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in pre-dialysis plasma oxalate levels during 6 weeks of treatment in subsets of subjects defined by dialysis regimen (HD or PD). [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]
- Duration of efficacy measured by pre dialysis plasma oxalate values from week 10 to week 14, following termination of OC5 treatment. [ Time Frame: 4 weeks after treatment (i.e. between Week 10 and Wk 14 of the study) ]
- Change in number of O. formigenes in faeces during 6 weeks of treatment. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]
- Change in total oxalate removal by dialysis and urinary clearance during 6 weeks of treatment in a limited number of subjects participating in the sub-study. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]Sub-study only to be performed in the patients from the Mayo Clinic.
- Adverse events (AEs) [ Time Frame: 10 weeks (from week 5 to week 14 of the study) ]
- Hematology [ Time Frame: 14 weeks (throughout the entire study) ]Blood samples taken for hematology at weeks 0, 4, 10 and 14. Complete blood count with differential and platelet count will be evaluated.
- Clinical chemistry [ Time Frame: 14 weeks (throughout the entire study) ]Blood samples taken for clinical chemistry at weeks 0, 4, 10 and 14 of the study. Blood Urea Nitrogen, creatinine, electrolytes (Na+, K+, Mg++, Ca++, HCO3+, Cl), glucose, pH, albumin, alkaline phosphatase, ALT, AST, total bilirubin, and total protein will be evaluated.
- Urinalysis [ Time Frame: 14 weeks (throughout the entire study) ]Urine samples will be taken at weeks 0, 4, 10 and 14 of the study. Protein, glucose and pH will be evaluated.
Original Secondary Outcome: Same as current
Information By: OxThera
Dates:
Date Received: November 20, 2013
Date Started: May 2014
Date Completion: December 2018
Last Updated: September 26, 2016
Last Verified: September 2016