Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis
Condition: Primary Hyperoxaluria
MeSH terms: Hyperoxaluria, Primary
Intervention: Oxalobacter formigenes
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: hyperoxaluria; oxalate; PH; dialysis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent (as applicable for the age of the subject). An appendix to the
             informed consent will be signed by patients continuing on treatment after week 14.

          2. Male or female subjects ≥ 2 years of age. Subjects have to be able to swallow size 4
             capsules twice daily for 6 weeks, or use a gastric tube that allows for administration
             of size 4 capsules.

          3. A diagnosis of PH (as determined by standard diagnostic methods).

          4. Patient should be on a stable dialysis regimen for at least two weeks before baseline.

          5. Pre-dialysis plasma oxalate ≥40 micromole/L.

          6. Patients receiving vitamin B6 must be receiving a stable dose for at least 3 months
             prior to screening and must remain on the stable dose during the study. Patients not
             receiving vitamin B6 at study entry must be willing to refrain from initiating vitamin
             B6 during study participation.

             Exclusion Criteria:

          7. Inability to swallow size 4 capsules twice daily for 6 weeks or using a gastric tube
             not suited for administration of size 4 capsules via the tube.

          8. Ongoing treatment with immunosuppressive medication.

          9. 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.

         10. Use of antibiotics to which O. formigenes is sensitive, including current antibiotic
             use, or antibiotics use within 14 days of initiating study medication.

         11. Current treatment with a separate ascorbic acid preparation. Standard of care vitamin
             supplement for patients on dialysis is allowed.

         12. Pregnancy.

         13. Women of childbearing potential who are not using adequate contraceptive precautions.
             Sexually active females, unless surgically sterile or at least 2 years
             post-menopausal, must be using a highly effective contraception (including oral,
             transdermal, injectable, or implanted contraceptives, IUD, abstinence, use of a condom
             by the sexual partner or sterile sexual partner) for 30 days prior to the first dose
             of OC5 and must agree to continue using such precautions during the clinical study.

         14. Presence of a medical condition that the Investigator considers likely to make the
             subject susceptible to adverse effect of study treatment or unable to follow study
             procedures.

         15. Participation in any study of an investigational product, biologic, device, or other
             agent within 30 days prior to the first dose of OC5 or not willing to forego other
             forms of investigational treatment during this study.