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Clinical Trials/NCT02012985
NCT02012985CompletedPhase 1

A Phase 1/2, Randomised, Placebo-controlled, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of OC5 to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria

OxThera8 sites in 3 countries28 target enrollmentStarted: December 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
28
Locations
8
Primary Endpoint
Change in urinary oxalate levels from Baseline to week 8 of treatment.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Signed informed consent (as applicable for the age of the subject).
  • •Male or female subjects ≥ 2 years of age (Germany & France) / Male or female subjects ≥ 5 years of age (United Kingdom)
  • •A diagnosis of PH type I, II or III (as determined by standard diagnostic methods).
  • •A mean urinary oxalate excretion of > 1.0 mmol/24h/1.73m2, based on at least three eligible urine collections performed during baseline (weeks 1-4).
  • •Renal function defined as an estimated GFR ≥ 40 ml/min normalised to 1.73m2 body surface area, or a creatinine clearance of ≥ 40 ml/min normalised to 1.73m2 body surface area.
  • •Subjects receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must not change the dose during the study. Subjects not receiving vitamin B6 at study entry must be willing to refrain from initiating pyridoxine during study participation.

Exclusion Criteria

  • •Inability to collect complete 24-hour urine samples. Each urine collection will be evaluated for completeness based on urine qualitative criteria.
  • •Inability to swallow size 4 capsules twice daily for 8 to 10 weeks.
  • •Subjects that have undergone transplantation (solid organ or bone marrow).
  • •The existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome.
  • •Use of antibiotics to which O. formigenes is sensitive, including chronic use, a history of more than two courses of antibiotic use during the past 6 months, current antibiotic use, or antibiotics use within 14 days of initiating study medication.
  • •Subjects who require immune suppressive therapy.
  • •Current treatment with ascorbic acid preparation.
  • •Pregnancy.
  • •Women of child-bearing potential who are not using adequate contraceptive precautions such as oral, transdermal, injectable, or implanted contraceptives, IUD, complete abstinence, use of a condom by the sexual partner, or sterile sexual partner.
  • •Presence of a medical condition that the Principal Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures.
  • •Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to screening or not willing to forego other forms of investigational treatment during this study.

Arms & Interventions

Oxabact OC5 capsules

Experimental

The active study drug consists of Oxalobacter formigenes OC5 in enteric-coated size-4 capsules. The dose (not less than (NLT) 1E+09 colony forming units (CFU)) will be administrated orally with breakfast and dinner as one capsule two times per day for 8 to 10 weeks.

Intervention: Oxabact OC5 capsules (Biological)

Placebo capsules

Placebo Comparator

The placebo study drug consists of microcrystalline cellulose in enteric-coated size-4 capsules. It has been manufactured to mimic the OC5 capsule. The dose will be administrated orally with breakfast and dinner as one capsule two times per day for 8 to 10 weeks.

Intervention: Placebo capsules (Drug)

Outcomes

Primary Outcomes

Change in urinary oxalate levels from Baseline to week 8 of treatment.

Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)

Secondary Outcomes

  • Adverse events(8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study))
  • Change in number of O. formigenes in faeces from Baseline to week 8 of treatment.(8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study))
  • Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects(8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study))
  • Number of subjects who reach urinary oxalate levels below 0.5, 0.7 and 1.0 mmol/24h/1.73m2 respectively from Baseline to week 8 of treatment.(8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study))
  • Change in plasma oxalate levels from Baseline to week 8 of treatment.(8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study))
  • Change in urinary oxalate levels from Baseline to week 4 of treatment.(8 weeks of active treatment (i.e. between Weeks 7 and 10 of the study))
  • Correlation between change in plasma oxalate levels and change in urinary oxalate levels, from Baseline to week 8 of treatment.(8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study))
  • Haematology(14 weeks (Throughout the study))
  • Clinical Chemistry(14 weeks (Throughout the study))
  • Urinalysis(14 weeks (Throughout the study))

Investigators

Sponsor
OxThera
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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