A Phase 2 interventional study of Oxalobacter formigenes in Primary Hyperoxaluria, sponsored by OxThera. Completed at 1 site in Germany. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2022-01-10.
Sponsored by OxThera · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.
42 studies on the registry are indexed under Hyperoxaluria, Primary; 11 are open to participants now.
This study's enrollment of 12 is below 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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
This is an open-label study so all patients will receive the active drug product, Oxalobacter formigenes, OC5. This will be administered as an enteric-coated capsules twice daily for 6 weeks of treatment. In Germany, the protocol has been amended such that patients can receive OC5 for a further 3 year of continued treatment after the initial part of the study.
Biological: Oxalobacter formigenes
The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner.
Also known as: Oxabact, OC5
Change in Pre Dialysis Plasma Oxalate (Total Plasma Oxalate) Level During Treatment With OC5 Compared With Baseline.
Total plasma oxalate measured in umol/L
Time frame: Baseline (average of week 2 & 4 pretreatment); treatment weeks 6, 8 & 10 (on treatment 2, 4, & 6 weeks); off treatment weeks 12 & 14 (2 & 4 weeks off treatment); patients were then eligible for treatment up to 3 years & oxalate was measured every 6 months
Change in Pre Dialysis Plasma Oxalate (Free Plasma Oxalate) Level During Study Compared With Baseline.
Comparison of free plasma oxalate compared to the four week baseline period.
Time frame: Baseline (average of week 2 & 4 pretreatment); treatment weeks 6, 8 & 10 (on treatment 2, 4, & 6 weeks); off treatment weeks 12 & 14 (2 & 4 weeks off treatment); patients were then eligible for treatment up to 3 years & oxalate was measured every 6 months
Change in Left Ventricular Ejection Fraction From Baseline.
Mean left ventricular ejection fraction measured as a percentage. Reference range 55-70%.
Time frame: At baseline and approximately every 6 months throughout the 3 year continued treatment.
Speckle Tracking Echocardiography
Global longitudinal strain (GLS), which measures the maximal shortening of myocardial longitudinal length during systole compared to the resting length in diastole. The normal range for GLS is considered to be \< -18%.
Time frame: At baseline and approximately every 6 months throughout the 3 year continued treatment.
| Milestone | Oxabact OC5 Capsule |
|---|---|
| Started | 12 |
| Completed | 9 |
| Not completed | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Underwent transplantation | 1 |
| Milestone | Oxabact OC5 Capsule |
|---|---|
| Started | 8 |
| Completed | 3 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Had liver transplant | 2 |
| Withdrew: Non-compliance with study drug | 2 |
Total plasma oxalate measured in umol/L
| μmol/L | Oxabact OC5 Capsule |
|---|---|
| Baseline value (average of week 2 and 4 pretreatment) | 147.57 ± 39.63 |
| 2 week treatment change from baseline | 11.34 ± 2.68 |
| 4 week treatment change from baseline | 7.46 ± 26.93 |
| 6 week treatment change from baseline | -5.68 ± 21.02 |
| 2 week off treatment change from baseline | -4.56 ± 18.23 |
| 4 week off treatment change from baseline | -8.41 ± 19.26 |
| continued treatment 24 weeks change from baseline | -35.99 ± 42.60 |
| continued treatment 52 weeks change from baseline | -33.99 ± 34.78 |
| continued treatment 76 weeks change from baseline | -28.04 ± 38.45 |
| continued treatment 104 weeks change from baseline | -67.36 ± 47.77 |
| continued treatment 128 weeks change from baseline | -46.25 ± 26.90 |
| continued treatment 156 weeks change from baseline | -44.65 ± 54.75 |
Comparison of free plasma oxalate compared to the four week baseline period.
| μmol/L | Oxabact OC5 Capsule |
|---|---|
| Baseline | 106.91 ± 35.50 |
| Change from baseline at the end of six weeks of treatment | 1.59 ± 18.77 |
| Change from baseline 4 weeks after treatment for 6 weeks | -6.50 ± 17.31 |
| Change from baseline at 24 weeks | -10.17 ± 15.27 |
| Change from baseline at 52 weeks | 2.52 ± 13.79 |
| Change from baseline at 76 weeks | -17.47 ± 13.71 |
| Change from baseline at 104 weeks | -47.29 ± 30.46 |
| Change from baseline at 128 weeks | -38.54 ± 10.59 |
| Change from baseline at 156 weeks | -5.36 ± 20.99 |
Mean left ventricular ejection fraction measured as a percentage. Reference range 55-70%.
| Percent | Oxabact OC5 Capsule |
|---|---|
| Baseline | 50.20 ± 10.26 |
| Week 24 | 59.43 ± 4.08 |
| Week 52 | 59.83 ± 5.85 |
| Week 80 | 59.60 ± 5.18 |
| Week 104 | 59.40 ± 5.94 |
| Week 128 | 58.00 ± 2.16 |
| Week 156 | 58.67 ± 7.57 |
Global longitudinal strain (GLS), which measures the maximal shortening of myocardial longitudinal length during systole compared to the resting length in diastole. The normal range for GLS is considered to be \< -18%.
| percentage of myocardial length change | Oxabact OC5 Capsule |
|---|---|
| Baseline value | -17.37 ± 5.30 |
| Week 24 | -19.15 ± 2.52 |
| Week 52 | -18.29 ± 3.27 |
| Week 80 | -19.53 ± 1.65 |
| Week 104 | -19.99 ± 2.96 |
| Week 128 | -19.60 ± 1.73 |
| Week 156 | -18.52 ± 1.65 |
Collected over Adverse events were collected from enrollment through last follow up visit, up to 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxabact OC5 Capsule | 0/12 (0%) | 7/12 (58.3%) | 10/12 (83.3%) |
| Event | Oxabact OC5 Capsule |
|---|---|
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 1/12 |
| Humerus fractureInjury, poisoning and procedural complications | 1/12 |
| Shunt occlusionInjury, poisoning and procedural complications | 1/12 |
| Shunt stenosisInjury, poisoning and procedural complications | 1/12 |
| Shunt thrombosisInjury, poisoning and procedural complications | 1/12 |
| Device related infectionInfections and infestations | 1/12 |
| Device related sepsisInfections and infestations | 1/12 |
| HyperkalaemiaMetabolism and nutrition disorders | 1/12 |
| Nervous system disorderNervous system disorders | 1/12 |
| Transient ischaemic attackNervous system disorders | 1/12 |
| Event | Oxabact OC5 Capsule |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 7/12 |
| DiarrhoeaGastrointestinal disorders | 5/12 |
| HypotensionVascular disorders | 3/12 |
| HyperkalaemiaMetabolism and nutrition disorders | 3/12 |
| VomitingGastrointestinal disorders | 2/12 |
| BursitisMusculoskeletal and connective tissue disorders | 2/12 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 2/12 |
| Dialysis device insertionSurgical and medical procedures | 2/12 |
Patients with primary hyperoxaluria (PH) who are on dialysis
| Age, Continuous(years) | Oxabact OC5 Capsule |
|---|---|
| Mean | 29.3 ± 17.0 |
| Sex: Female, Male(Participants) | Oxabact OC5 Capsule |
|---|---|
| Female | 4 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | Oxabact OC5 Capsule |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Oxabact OC5 Capsule |
|---|---|
| France | 1 |
| Germany | 11 |
| Primary hyperoxaluria Type I(Participants) | Oxabact OC5 Capsule |
|---|---|
| Count of participants | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2014 to primary completion in Jan 2020, 68 months.
Results were first posted in Dec 2021, 1 year 10 months after primary completion. A results delay was requested in Jan 2021.
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxalobacter formigenes
OxThera