primary hyperoxaluria MedDRA version: 12.0 Level: LLT Classification code 10020703 Term: Hyperoxaluria
Conditions
Interventions
Product Name: Oxabact - Oxalobacter formigenes, strain HC-1
Product Code: OC3 (buffer)
Pharmaceutical Form: Powder for oral suspension
Current Sponsor code: OC3 drug substance
Other descriptive name:
Sponsors
OxThera IP AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent (as applicable for the age of the subject) 2. Male or female subjects = 2 years of age 3. A diagnosis of PH I or PH II (as determined by standard diagnosis methods) 4. A mean urinary oxalate excretion of > 1.0 mmol/1.73m2/day at collections performed during screening. 5. Renal function defined as an estimated GFR = 40 ml/min normalized to 1.73m2 body surface area, or a creatinine clearance of = 40 ml/min normalized to 1.73m2 body surface area. 6. Subjects receiving pyridoxine must be receiving a stable dose for at least 3 months prior to entry into the study and must remain on the stable dose during the study. Subjects not receiving pyridoxine 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 7. Inability to collect two complete 24-hour urine samples. Each urine collection will be evaluated for completeness based on the urine acceptance criteria outlined in section 11.1. 8. Subjects diagnosed as PH I who are pyridoxine naïve. 9. Subjects that have undergone transplantation (solid organ or bone marrow). 10. The existence of secondary hyperoxaluria, e.g. chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome. 11. Current systemic (oral, IM, IV) antibiotic use or received systemic antibiotics within 14 days of study enrolment. 12. History of a recurrent infection requiring >2 courses of systemic antibiotics in the past 6 months, or chronic antimicrobial suppression. 13. Subjects who require immune suppressive therapy (including prednisone > 10mg daily for more than 2 weeks). 14. Current treatment with a separate ascorbic acid preparation. Ascorbic acid up to 250mg/day as a component of a multivitamin formulation is not excluded. 15. Known hypersensitivity to esomeprazol (or any of the other ingredients of this medicine), or to any other proton pump inhibitor medicine. (Nexium contraindication) 16. Concomitant treatment with atazanavir. (Nexium contraindication) 17. Pregnancy. 18. Women of child-bearing 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 OxabactTM and must agree to continue using such precautions during the clinical study. 19. 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. Note: Subjects from correctional facilities or asylums and subjects who are mentally handicapped are not to be included in the study. 20. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to randomization or not willing to forego other forms of investigational treatment during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Oxabact(TM) to reduce urinary oxalate levels (molar oxalate to creatinine ratio) from Baseline to Week 24 in subjects with Primary Hyperoxaluria (PH).;Primary end point(s): - Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24.;Secondary Objective: *To evaluate the safety of OxabactTM administered for 24 weeks in subjects with Primary Hyperoxaluria (PH). *To evaluate the efficacy of OxabactTM from Baseline to Week 24 as regards: - Reduction in urinary oxalate levels in subsets of subjects, based on disease characteristics and age. - Percentage of subjects who have =20% reduction in urinary oxalate levels. - Reduction in plasma oxalate levels and any correlation to reduction in urinary oxalate levels. - Frequency of Stone Events (i.e. nephrolithiasis or markers thereof). *To evaluate the efficacy of OxabactTM from Baseline to Week 8. | — |
Countries
Germany, Netherlands
Outcome results
None listed