Primary Hyperoxaluria (PH) MedDRA version: 20.1 Level: LLT Classification code 10020702 Term: Hyperoxalemia System Organ Class: 100000004861
Conditions
Sponsors
OxThera Intellectual Property AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent (as applicable for the age of the subject). 2. Participation in and completion of the ePHex study. 3. Subjects who had received vitamin B6 during the ePHex study should maintain a stable dose. Subjects not receiving vitamin B6 during the ePHex study 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: 15 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
Exclusion criteria
Exclusion criteria: 4. Inability to swallow size 4 capsules. 5. Use of antibiotics to which O. formigenes is sensitive. 6. Current treatment with a separate ascorbic acid preparation. 7. Pregnant women (or women who are planning to become pregnant) or lactating women. 8. Women of childbearing potential who are not using adequate contraceptive precautions. 9. 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). 10. Participation in any interventional study of another investigational product, biologic, device, or other agent 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® following two years continued treatment in subjects who have completed the Oxabact® OC5-DB-02 study.;Secondary Objective: To obtain additional safety data from two years continuous treatment with Oxabact®.;Primary end point(s): Change from baseline in kidney function (eGFR) ;Timepoint(s) of evaluation of this end point: after 12 and 24 months of open-label Oxabact® treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: 1. Change from baseline in total plasma oxalate concentration. 2. Frequency of kidney stones events. Stone events are defined as: (i) Subject- or investigator-reported symptoms, or (ii) Stone passages or removals, or (iii) Increase in the number of kidney stones as assessed by ultrasound. Other endpoints: 3. Change from baseline in myocardial function as measured by Speckle Tracking and traditional echocardiography. 4. Change from baseline in free plasma oxalate concentration. 5. Change from baseline in urinary oxalate. 6. Change from baseline in grade of nephrocalcinosis as assessed by ultrasound. 7. Change in number of O. formigenes in stool. 8. Association between change in number of O. formigenes in stool and change in total plasma oxalate concentration. 9. Change from baseline in score of Quality of Life questionnaire. 10. Change from baseline in markers for renal function, renal tubular capacity and inflammation: Urine: magnesium, phosphorus, citrate, calcium, glycolate, creatinine, urea, calcium oxalate crystals, pH, osmolality and urinary volume. Blood: magnesium, phosphorus, citrate, calcium, BUN, ALP, bicarbonate, CRP, WBC, creatinine and cystatine C. ;Timepoint(s) of evaluation of this end point: after 12 and 24 months of open-label Oxabact® treatment | — |
Countries
Belgium, Germany, Spain, Tunisia, United Kingdom, United States
Contacts
Public ContactDirector of Regulatory Affairs
OxThera Intellectual Property AB
Outcome results
None listed