Phase II/III Oxabact™ Study

Phase 2

Completed

• Conditions: Primary hyperoxaluria; Nutritional, Metabolic, Endocrine; Other disorders of carbohydrate metabolism

• Registration Number: ISRCTN63711065
• Lead Sponsor: OxThera IP AB (Sweden)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28718073 [added 20/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-22
• Study Completion: 2010-09-30
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Signed informed consent (as applicable for the age of the subject)
2. Male or female subjects greater than or equal to 2 years of age
3. A mean urinary oxalate excretion of greater than 1.0 mmol/1.73 m2/day from eligible urine collections performed during screening
4. A diagnosis of PH I or PH II by one of the following:
4.1. Liver biopsy confirmation of deficient liver specific peroxisomal alanine-glyoxylate aminotransferase (AGT) or mislocalisation of AGT from peroxisomes to mitochondria (PH I) or deficient glyoxylate reductase/hydroxypyruvate reductase (GRHPR) activity (PH II)
4.2. Homozygosity or compound heterozygosity for a known mutation in the causative genes for PH I and PH II
4.3. Increased glycolate excretion for PH I or increased L-glycerate excretion for PH II
5. 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.
6. Renal function defined as an estimated glomerular filtration rate (GFR) greater than or equal to 40 ml/min normalised to 1.73 m2 body surface area, or a creatinine clearance of greater than or equal to 40 ml/min normalised to 1.73 m2 body surface area

Exclusion Criteria

1. Inability to collect two complete 24-hour urine samples
2. Subjects diagnosed as PH I who are pyridoxine naive
3. Subjects that have undergone transplantation (solid organ or bone marrow)
4. The existence of secondary hyperoxaluria, e.g. chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome
5. Current systemic (oral, intramuscular [IM], intravenous [IV]) antibiotic use or received systemic antibiotics within 14 days of study enrolment
6. History of a recurrent infection requiring greater than two courses of systemic antibiotics in the past 6 months, or chronic antimicrobial suppression
7. Subjects who require immune suppressive therapy (including prednisone greater than 10 mg daily for more than 2 weeks)
8. Current treatment with a separate ascorbic acid preparation. Ascorbic acid up to 250 mg/day as a component of a multivitamin formulation is not excluded.
9. Known hypersensitivity to esomeprazol (or any of the other ingredients of this medicine), or to any other proton pump inhibitor medicine (Nexium® contraindication)
10. Concomitant treatment with atazanavir (Nexium® contraindication)
11. Pregnancy
12. 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, intrauterine devide (IUD), abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of Oxabact™ and must agree to continue using such precautions during the clinical study.
13. 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.
14. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to randomisation or not willing to forego other forms of investigational treatment during this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from baseline to week 24