A phase II/III, double-blind, randomised, placebo-controlled, multicentre study to evaluate the efficacy and safety of Oxabact™ to reduce urinary oxalate in subjects with primary hyperoxaluria

OxThera IP AB (Sweden)0 sites35 target enrollmentJanuary 22, 2010

Overview

Registry

who.int

Start Date

January 22, 2010

End Date

September 30, 2010

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

OxThera IP AB (Sweden)

•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

•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)