A Phase 3 interventional study of Oxabact OC5 - Oxalobacter formigenes HC-1 and Placebo in Primary Hyperoxaluria, sponsored by OxThera. Completed at 10 sites in 7 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2021-12-10.
Sponsored by OxThera · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of OC5 in patients with PH.
To evaluate the efficacy of Oxabact following 52 weeks treatment in subjects with maintained kidney function, but below the lower limit of the normal range (estimated glomerular filtration rate [eGFR] \< 90 ml/min/1.73 m2) and a total plasma oxalate (Pox) concentration ≥ 10 μmol/L. Parameters to be evaluated include the ability to stabilise/reduce Pox concentration, to stabilise/improve kidney function and to reduce oxalate deposits in primary hyperoxaluria (PH) subjects.
42 studies on the registry are indexed under Hyperoxaluria, Primary; 11 are open to participants now.
This study's enrollment of 25 is close to the median of 24 across 26 interventional studies indexed under Hyperoxaluria, Primary.
Browse Hyperoxaluria, Primary studies →OxThera is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oxabact OC5 - Oxalobacter formigenes HC-1
Biological: Oxabact OC5 - Oxalobacter formigenes HC-1
Placebo
Other: Placebo
Active study drug
Placebo
Change From Baseline in Plasma Oxalate Concentration After 52 Weeks of Treatment
Change from baseline in total plasma oxalate concentration after 52 weeks of treatment in micromole/liter
Time frame: 52 weeks
Change From Baseline in Kidney Function
Evaluation based on eGFR calculation using the 2009 creatinine-based "Schwartz bedside" equation (for children below 18 years of age) (Schwartz et al., 2009) and 2009 creatinine-based CKD-EPI equation for adults (Levey et al., 2009). Subjects who turn 18 during the study period were continuously evaluated using the Schwartz equation, ie the equation used at baseline was kept throughout the study.
Time frame: 52 weeks
Frequency of Kidney Stone Events
Number of kidney stone events for each patient
Time frame: Through week 48
Recruitment began 09 January 2018. Primary study completion 15 April 2021
| Milestone | Oxabact OC5 Capsules | Placebo Capsules |
|---|---|---|
| Started | 13 | 12 |
| Completed | 13 | 11 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
Change from baseline in total plasma oxalate concentration after 52 weeks of treatment in micromole/liter
| micromole/liter | Oxabact OC5 Capsules | Placebo Capsules |
|---|---|---|
| Baseline value | 14.8 ± 5.7 | 14.4 ± 5.4 |
| Change from baseline to 52 weeks | -0.71 ± 1.34 | 2.35 ± 1.46 |
Evaluation based on eGFR calculation using the 2009 creatinine-based "Schwartz bedside" equation (for children below 18 years of age) (Schwartz et al., 2009) and 2009 creatinine-based CKD-EPI equation for adults (Levey et al., 2009). Subjects who turn 18 during the study period were continuously evaluated using the Schwartz equation, ie the equation used at baseline was kept throughout the study.
| millilitres/minute/1.73m2 | Oxabact OC5 Capsules | Placebo Capsules |
|---|---|---|
| Change From Baseline in Kidney Function | -1.35 ± 2.68 | -0.06 ± 3.12 |
Number of kidney stone events for each patient
| Number of kidney stone events | Oxabact OC5 Capsules | Placebo Capsules |
|---|---|---|
| Frequency of Kidney Stone Events | 7 | 8 |
Collected over Adverse events were collected over the 52 week study period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxabact OC5 Capsules | 0/13 (0%) | 3/13 (23.1%) | 13/13 (100%) |
| Placebo Capsules | 0/12 (0%) | 4/12 (33.3%) | 11/12 (91.7%) |
| Event | Oxabact OC5 Capsules | Placebo Capsules |
|---|---|---|
| Calculus urinaryRenal and urinary disorders | 0/13 | 2/12 |
| Renal colicRenal and urinary disorders | 1/13 | 1/12 |
| NephrolithiasisRenal and urinary disorders | 0/13 | 1/12 |
| Renal impairmentRenal and urinary disorders | 0/13 | 1/12 |
| Urinary tract obstructionRenal and urinary disorders | 0/13 | 1/12 |
| Bacterial pyelonephritisInfections and infestations | 0/13 | 1/12 |
| Flank painMusculoskeletal and connective tissue disorders | 0/13 | 1/12 |
| UreterolithiasisRenal and urinary disorders | 1/13 | 0/12 |
| Escherichia urinary tract infectionInfections and infestations | 1/13 | 0/12 |
| Pyelonephritis acuteInfections and infestations | 1/13 | 0/12 |
| Event | Oxabact OC5 Capsules | Placebo Capsules |
|---|---|---|
| VomitingGastrointestinal disorders | 1/13 | 4/12 |
| NasopharyngitisInfections and infestations | 2/13 | 2/12 |
| TonsillitisInfections and infestations | 2/13 | 2/12 |
| Urinary tact infectionInfections and infestations | 1/13 | 2/12 |
| GastroenteritisInfections and infestations | 0/13 | 2/12 |
| Flank painMusculoskeletal and connective tissue disorders | 2/13 | 2/12 |
| PyrexiaGeneral disorders | 2/13 | 2/12 |
| Calculus urinaryRenal and urinary disorders | 1/13 | 2/12 |
| NephrolithiasisRenal and urinary disorders | 1/13 | 2/12 |
| Vitamin D deficiencyMetabolism and nutrition disorders | 2/13 | 0/12 |
| Age, Categorical(Participants) | Oxabact OC5 Capsules | Placebo Capsules | Total |
|---|---|---|---|
| <=18 years | 10 | 8 | 18 |
| Between 18 and 65 years | 3 | 4 | 7 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Oxabact OC5 Capsules | Placebo Capsules | Total |
|---|---|---|---|
| Mean | 12.9 ± 6.4 | 18.3 ± 16.5 | 15.5 ± 12.4 |
| Sex: Female, Male(Participants) | Oxabact OC5 Capsules | Placebo Capsules | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 4 | 7 | 11 |
| Race (NIH/OMB)(Participants) | Oxabact OC5 Capsules | Placebo Capsules | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 12 | 12 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Oxabact OC5 Capsules | Placebo Capsules | Total |
|---|---|---|---|
| Belgium | 1 | 2 | 3 |
| United States | 0 | 1 | 1 |
| United Kingdom | 1 | 2 | 3 |
| Tunisia | 3 | 1 | 4 |
| Germany | 2 | 4 | 6 |
| Spain | 6 | 2 | 8 |
| Primary Hyperoxaluria Type(Participants) | Oxabact OC5 Capsules | Placebo Capsules | Total |
|---|---|---|---|
| PH Type I | 13 | 11 | 24 |
| PH Type II | 0 | 1 | 1 |
| Stage of Chronic Kidney Disease(Participants) | Oxabact OC5 Capsules | Placebo Capsules | Total |
|---|---|---|---|
| Stage I | 1 | 2 | 3 |
| Stage II | 11 | 5 | 16 |
| Stage III | 1 | 5 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Apr 2021, 39 months.
Results were first posted in Dec 2021, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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