Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
OxThera |
---|---|
Information provided by: | OxThera |
ClinicalTrials.gov Identifier: | NCT00638703 |
The main purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
Condition | Intervention | Phase |
---|---|---|
Primary Hyperoxaluria |
Biological: Oxalobacter formigenes Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, International Study to Evaluate the Efficacy and Safety of OxabactTM to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria |
Estimated Enrollment: | 50 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental
Size 2 enteric coated capsule containg lyophilized Oxalobacter formigenes
|
Biological: Oxalobacter formigenes
NLT (not less than) 10^7 CFU Oxalobacter formigenes twice daily for 24 weeks
|
II: Placebo Comparator
Size 2 enteric coated capsule containg placebo
|
Drug: Placebo
placebo
|
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documentation of diagnosis of PH I or PH II by any one of the following:
Subjects receiving pyridoxine must be receiving a stable dose for at least 3 months prior to entry in to the study and must remain on the stable dose during the study. Other (non-pyridoxine naïve) subjects (e.g.
Pyridoxine non-responder: <30% reduction of the urine oxalate levels) not receiving pyridoxine at study entry must be willing to refrain from initiating pyridoxine during study participation. Note: There will be no pyridoxine-naïve subjects enrolled in the study.
Exclusion Criteria:
Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions. Sexually active females, unless surgically sterile or at least 2 years post-menopausal, must be using a highly effective contraception (including oral, transdermal, injectable, or implanted contraceptives, IUD, abstinence, use of a condom by the sexual partner, or sterile sexual partner) for 30 days prior to the first dose of OxabactTM and must agree to continue using such precautions during the clinical study. Note: A highly effective method of birth control is defined as one that results in a low failure rate (i.e.
less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomised partner.
United States, Minnesota | |
Mayo Clinic (Department of Pediatric Nephrology) | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Dawn Milliner, M.D | Mayo Clinic |
Responsible Party: | OxThera Inc ( Albert Fosmoe, Chief Regulatory Officer ) |
Study ID Numbers: | OC3-DB-01, DB-01 |
Study First Received: | March 12, 2008 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00638703 History of Changes |
Health Authority: | European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
hyperoxaluria PH oxalate |
Metabolism, Inborn Errors Metabolic Diseases Hyperoxaluria, Primary Genetic Diseases, Inborn Urologic Diseases |
Hyperoxaluria Kidney Diseases Metabolic Disorder Oxalosis |
Metabolism, Inborn Errors Metabolic Diseases Hyperoxaluria, Primary Genetic Diseases, Inborn |
Urologic Diseases Hyperoxaluria Kidney Diseases Carbohydrate Metabolism, Inborn Errors |