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