A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Condition: Primary Hyperoxaluria
MeSH terms: Hyperoxaluria, Primary
Intervention: Oxabact OC5 - Oxalobacter formigenes HC-1; Placebo
Intervention description: Active study drug; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent (as applicable for the age of the subject)

          2. A diagnosis of PH (as determined by standard diagnostic methods).

          3. eGFR < 90 ml/min/1.73 m2. The Schwartz formula will be used to estimate GFR for
             children (age below 18), and CKD-EPI formula will be used for adults (age 18 or
             above).

          4. Plasma oxalate concentration ≥10 μmol/L in total plasma oxalate.

          5. Male or female patients ≥ 2 years of age.

          6. Patients 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. Patients not
             receiving vitamin B6 at study entry must be willing to refrain from initiating
             pyridoxine during study participation.

        Exclusion Criteria:

          1. Inability to swallow size 4 capsules.

          2. Subjects that have undergone transplantation (solid organ or bone marrow).

          3. Patients requiring dialysis or at immediate risk for kidney failure or expected to be
             in need of dialysis during the study period.

          4. 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.

          5. Use of antibiotics to which O. formigenes is sensitive. (This includes current
             antibiotic use, or antibiotics use within 14 days of initiating study medication).

          6. Current treatment with a separate ascorbic acid preparation.

          7. Pregnant women (or women who are planning to become pregnant) or lactating women.

          8. Women of childbearing potential who are not using adequate contraceptive precautions.
             Please see section 7.3 regarding requirements for contraception.

          9. 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 or any condition that is likely to interfere with the study drug mechanism
             of action (such as abnormal GI function).

         10. Participation in any interventional study of another investigational product,
             biologic, device, or other agent within 60 days prior to the first dose of OC5 or not
             willing to forego other forms of investigational treatment during this study.