A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
NCT ID: NCT03116685
Last Updated: 2021-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2018-01-09
2021-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oxabact OC5 capsules
Oxabact OC5 - Oxalobacter formigenes HC-1
Oxabact OC5 - Oxalobacter formigenes HC-1
Active study drug
Placebo capsules
Placebo
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oxabact OC5 - Oxalobacter formigenes HC-1
Active study drug
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. A diagnosis of PH (as determined by standard diagnostic methods).
3. eGFR \< 90 ml/min/1.73 m2. The Schwartz formula will be used to estimate GFR for children (age below 18), and CKD-EPI formula will be used for adults (age 18 or above).
4. Plasma oxalate concentration ≥10 μmol/L in total plasma oxalate.
5. Male or female patients ≥ 2 years of age.
6. Patients 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. Patients not receiving vitamin B6 at study entry must be willing to refrain from initiating pyridoxine during study participation.
Exclusion Criteria
2. Subjects that have undergone transplantation (solid organ or bone marrow).
3. Patients requiring dialysis or at immediate risk for kidney failure or expected to be in need of dialysis during the study period.
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. (This includes current antibiotic use, or antibiotics use within 14 days of initiating study medication).
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. Please see section 7.3 regarding requirements for contraception.
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 within 60 days prior to the first dose of OC5 or not willing to forego other forms of investigational treatment during this study.
2 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
OxThera
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gesa Schalk, MD
Role: PRINCIPAL_INVESTIGATOR
KindernierenZentrum, Bonn, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Hospital
Nashville, Tennessee, United States
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Hôpital Robert Debré
Paris, , France
Kindernierenzentrum Bonn
Bonn, , Germany
Hospital Vall d' Hebron
Barcelona, , Spain
Hédi Chaker University Hospital
Sfax, , Tunisia
Sahloul University Hospital
Sousse, , Tunisia
Charles Nicolle University Hospital
Tunis, , Tunisia
Royal Free Hospital
London, , United Kingdom
Nottingham Children's Hospital
Nottingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OC5-DB-02
Identifier Type: -
Identifier Source: org_study_id