A study to find out of if Oxabact is an effective and safe treatment for patients with primary hyperoxaluria compared to placebo

Phase 1

Conditions: Primary Hyperoxaluria (PH)
MedDRA version: 20.1Level: LLTClassification code 10020702Term: HyperoxalemiaSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2017-000684-33-DE

Lead Sponsor: OxThera Intellectual Property AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

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 equation will be used to estimate GFR for children (age below 18), and CKD-EPI equation will be used for adults (age 18 or above).
4. Plasma oxalate concentration =10 µmol/L in total plasma oxalate.
5. Male or female subjects = 2 years of age.
6. 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

7. Inability to swallow size 4 capsules.
8. Subjects that have undergone transplantation (solid organ or bone marrow).
9. Subjects requiring dialysis or at immediate risk for kidney failure or expected to be in need of dialysis during the study period.
10. 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.
11. Use of antibiotics to which O. formigenes is sensitive. (This includes current antibiotic use, or antibiotics use within 14 days of initiating study medication.)
12. Current treatment with a separate ascorbic acid preparation.
13. Pregnant women (or women who are planning to become pregnant) or lactating women.
14. Women of childbearing potential who are not using adequate contraceptive precautions.
15. 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).
16. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of Oxabact® following 52 weeks treatment in<br>patients with maintained kidney function, but below the lower limit of the normal range (eGFR < 90 ml/min/1.73 m2) and a total plasma oxalate concentration = 10 µmol/L at baseline<br>;Secondary Objective: To obtain additional safety data from 52 weeks continuous treatment<br>with Oxabact®<br>;Primary end point(s): Change from baseline in total plasma oxalate concentration after 52 weeks of treatment.;Timepoint(s) of evaluation of this end point: after 52 weeks of treatment

Secondary Outcome Measures

Name	Time	Method

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