- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02012985
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria
October 14, 2015 updated by: OxThera
A Phase 1/2, Randomised, Placebo-controlled, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of OC5 to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bordeaux, France, 33076
- Hôpital des Enfants, Centre de référence maladies rénales rares du Sud-Ouest (SORARE), CHU de Bordeaux
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Lyon, France, 69677 Bron
- Hôpital Femme Mère Enfant, Lyon - Paediatric Dept
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Paris, France, 75015
- Hôpital Necker-Enfants Malades,Centre de référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte (MARHEA)
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Cedex 19
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Paris, Cedex 19, France, 75945
- Hôpital Robert-Debré, Néphrologie Pédiatrique
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Bonn, Germany, DE-53113
- Universitätsklinikum Bonn, Dept of Paediatric Nephrology
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Birmingham, United Kingdom, B4 6NH
- Birmingham Children's Hospital NHS Foundation Trust - Dept of Nephrology
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London, United Kingdom, NW3 2QG
- Royal Free Hospital -UCL Centre for Nephrology
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London, United Kingdom, WCIN 3JH
- Great Ormond Street Hospital for Children NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent (as applicable for the age of the subject).
- Male or female subjects ≥ 2 years of age (Germany & France) / Male or female subjects ≥ 5 years of age (United Kingdom)
- A diagnosis of PH type I, II or III (as determined by standard diagnostic methods).
- 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).
- 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.
- 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.
Exclusion Criteria:
- Inability to collect complete 24-hour urine samples. Each urine collection will be evaluated for completeness based on urine qualitative criteria.
- Inability to swallow size 4 capsules twice daily for 8 to 10 weeks.
- Subjects that have undergone transplantation (solid organ or bone marrow).
- 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.
- 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 antibiotics use within 14 days of initiating study medication.
- Subjects who require immune suppressive therapy.
- Current treatment with ascorbic acid preparation.
- Pregnancy.
- 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.
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Oxabact OC5 capsules
The active study drug consists of Oxalobacter formigenes OC5 in enteric-coated size-4 capsules.
The dose (not less than (NLT) 1E+09 colony forming units (CFU)) will be administrated orally with breakfast and dinner as one capsule two times per day for 8 to 10 weeks.
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The dose will be not less than (NLT) 1E+09 colony forming units (CFU) twice daily for 8 to 10 weeks.
The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner.
Other Names:
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Placebo Comparator: Placebo capsules
The placebo study drug consists of microcrystalline cellulose in enteric-coated size-4 capsules.
It has been manufactured to mimic the OC5 capsule.
The dose will be administrated orally with breakfast and dinner as one capsule two times per day for 8 to 10 weeks.
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An enteric-coated placebo capsule manufactured to mimic the OC5 capsule.
The capsule will be administered orally with breakfast and dinner twice daily for 8 to 10 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in urinary oxalate levels from Baseline to week 8 of treatment.
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects defined by:
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8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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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.
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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Change in plasma oxalate levels from Baseline to week 8 of treatment.
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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Change in urinary oxalate levels from Baseline to week 4 of treatment.
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 10 of the study)
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8 weeks of active treatment (i.e. between Weeks 7 and 10 of the study)
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Correlation between change in plasma oxalate levels and change in urinary oxalate levels, from Baseline to week 8 of treatment.
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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Change in number of O. formigenes in faeces from Baseline to week 8 of treatment.
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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Adverse events
Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study)
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Haematology
Time Frame: 14 weeks (Throughout the study)
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Blood samples taken for hematology at weeks 0, 5, 10 and 14.
Complete blood count with differential and platelet count evaluated.
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14 weeks (Throughout the study)
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Clinical Chemistry
Time Frame: 14 weeks (Throughout the study)
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Blood samples taken for clinical chemistry at weeks 0, 5, 10 and 14.
Blood Urea Nitrogen, creatinine, electrolytes (Na+, K+, Mg++, Ca++, HCO3+, Cl), glucose, pH, albumin, alkaline phosphatase, ALT, AST, total bilirubin and total protein evaluated.
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14 weeks (Throughout the study)
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Urinalysis
Time Frame: 14 weeks (Throughout the study)
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Urine samples will be taken at weeks 0, 5, 10 and 14 of the study.
Protein, glucose and pH evaluated.
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14 weeks (Throughout the study)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernd Hoppe, MD PhD, Universitätsklinikum Bonn, Dept of Paediatric Nephrology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
December 11, 2013
First Submitted That Met QC Criteria
December 11, 2013
First Posted (Estimate)
December 17, 2013
Study Record Updates
Last Update Posted (Estimate)
October 16, 2015
Last Update Submitted That Met QC Criteria
October 14, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OC5-DB-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Hyperoxaluria
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Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyEnrolling by invitationKidney Diseases | Urologic Diseases | Genetic Disease | Primary Hyperoxaluria Type 1 (PH1) | Primary Hyperoxaluria Type 2 (PH2) | Primary Hyperoxaluria Type 3 (PH3)United States, France, Germany, Japan, Lebanon, Spain, United Kingdom, Australia, Canada, Italy, Netherlands, Norway, Turkey
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Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyRecruitingPrimary Hyperoxaluria Type 3 | Primary Hyperoxaluria Type 2 | Primary Hyperoxaluria Type 1 | Primary HyperoxaluriaUnited States, Canada, Lebanon, Turkey, United Kingdom, Germany, Italy, Japan, Poland, Spain, United Arab Emirates
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Alnylam PharmaceuticalsCompletedPrimary Hyperoxaluria Type 1 (PH1)France, United Kingdom, Netherlands, Israel, Germany
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Novo Nordisk A/SCompletedKidney Diseases | Urologic Diseases | Genetic Disease | Primary Hyperoxaluria Type 1 (PH1) | Primary Hyperoxaluria Type 2 (PH2)Poland, United States, United Kingdom, New Zealand, Australia, Canada, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Romania, Spain
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BiocodexExystatNot yet recruitingPrimary Hyperoxaluria Type 3 | Primary Hyperoxaluria Type 2 | Primary Hyperoxaluria Type 1
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Alnylam PharmaceuticalsCompletedPrimary Hyperoxaluria Type 1 (PH1)United States, France, United Kingdom, Switzerland, Netherlands, Israel, Germany, United Arab Emirates
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Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyAvailablePrimary Hyperoxaluria Type 1 (PH1)
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VA New York Harbor Healthcare SystemMayo Clinic; New York UniversityUnknownOxalate, Primary Hyperoxaluria, MicrobiomeUnited States
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Dicerna Pharmaceuticals, Inc.CompletedPrimary Hyperoxaluria Type 3United States, Germany, Netherlands, United Kingdom
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University of CologneCompletedPrimary Hyperoxaluria Type IGermany
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