Primary Hyperoxaluria (PH) MedDRA version: 17.0 Level: PT Classification code 10020703 Term: Hyperoxaluria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Oxabact_Oxalobacter formigenes, strain HC-1
Product Code: OC5 (enteric-coated capsules)
Pharmaceutical Form: Capsule
INN or Proposed INN: OXALOBACTER FORMIGENES, STRAIN HC 1
Current Spon
Sponsors
OxThera 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 type I, II or III (as determined by standard diagnostic methods). 4.A mean urinary oxalate excretion of = 1.0 mmol/24h/1.73m2 based on at least three eligible urine collections performed during baseline (weeks 1-4). 5.Renal function defined as an estimated GFR = 40 ml/min normalised to 1.73m2 body surface area, or a creatinine clearance of = 40 ml/min normalised to 1.73m2 body surface area. 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: 16 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Inability to collect complete 24-hour urine samples. Each urine collection will be evaluated for completeness based on the urine qualitative criteria. 2.Inability to swallow size 4 capsules twice daily for 8 to 10 weeks. 3.Subjects that have undergone transplantation (solid organ or bone marrow). 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, including chronic use, a history of more than two courses of antibiotic use during the past 6 months, current antibiotic use, or antibiotic use within 14 days of initiating study medication. 6.Subjects who require immune suppressive therapy. 7.Current treatment with ascorbic acid preparation. 8.Pregnancy 9.Women of child-bearing potential who are not using adequate contraceptive precautions, such as oral, transdermal, injectable, or implanted contraceptives, IUD, complete abstinence, use of a condom by the sexual partner, or sterile sexual partner 10.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. 11.Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to screening 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 OC5 to reduce urinary oxalate levels during 8 weeks in subjects with Primary Hyperoxaluria (PH).;Secondary Objective: To evaluate the safety of OC5 administered for 8 weeks in subjects with PH. To evaluate the efficacy of OC5 to reduce plasma oxalate levels during 8 weeks in subjects with PH. To evaluate changes in number of O. formigenes in faeces following administration of OC5.;Primary end point(s): Change in urinary oxalate levels from Baseline to week 8 of treatment.;Timepoint(s) of evaluation of this end point: Baseline is the mean of urinary oxalate levels from week 1, 2, 3 and 4 of the study. The week 8 of treatment measurement is the mean of the urinary oxalate level at week 12 and week 14 of the study (i.e. week 6 and week 8 of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects defined by: - baseline urinary oxalate level, above and below 1.5 mmol/24h/1.73m2. - concomitant vitamin B6 therapy and no vitamin B6 therapy. - eGFR of =90 mL/min/1.73m2 (normal renal function) and < 90 mL/min/ 1.73m2 (mild to moderate reduction in renal function). - age below 18 and age 18 or above. 2. Number of subjects who reach urinary oxalate levels below 0.5, 0.7 and 1.0 mmol/24h/1.73m2 respectively from Baseline to week 8 of treatment. 3. Change in plasma oxalate levels from Baseline to week 8 of treatment. 4. Change in urinary oxalate from Baseline to week 4 of treatment. 5. Correlation between change in plasma oxalate levels and change in urinary oxalate levels from Baseline to week 8 of treatment. 6. Change in number of O.formigenes in faeces from Baseline to week 8 of treatment. 10. Safety: – Adverse events (AE’s), hematology, clinical chemistry, urinalysis.;Timepoint(s) of evaluation of this end point: Baseline is the mean of urinary oxalate levels from week 1, 2, 3 and 4 of the study. The week 8 of treatment measurement is the mean of the urinary oxalate level at week 12 and week 14 of the study (i.e. week 6 and week 8 of treatment). The week 4 of treatment measurement is the mean of the urinary oxalate levels at week 8 and 10 of the study (i.e. week 2 and week 4 of treatment). | — |
Countries
Germany, United Kingdom
Contacts
Public ContactDirector of Clinical Operations
OxThera AB
Outcome results
None listed