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A clinical trial evaluating a new treatment for PH is now open for enrollment A Phase III trial evaluating the effectiveness and safety of Oxalobacter formigenes treatment in patients with Primary Hyperoxaluria (PH), is now actively recruiting patients in the USA and Europe. Oxalobacter formigenes is a unique oxalate degrading bacteria naturally present in the intestine of 50-70% of the general population. This bacterium uses only oxalate as its energy source and therefore it efficiently degrades oxalate. When Oxalobacter formigenes is taken, the oxalate degrading bacteria are released into the intestine where they continuously degrade oxalate. This excessive break down of oxalate in the intestine may help dissolve the extra oxalate being produced by the liver in patients with PH. If the bacterium can do this, less oxalate will be filtered through the kidneys into the urine. Participants in this study will receive Oxalobacter formigenes or a placebo. The duration of the study is approximately 6 months and the study medication is given orally twice a day. Eligibility for this study will be determined at the study center. If you or your child has PH and are at least 2 years old and interested in participating in this trial, please contact (or ask your doctor to contact) the clinical trial center closest to you. For further information on the trial follow this link to ClinicalTrial.gov: http://www.clinicaltrial.gov/ct2/show/NCT01037231?term=oxalobacter&rank=1 If you are from the USA please contact:Mayo Clinic (Department of Pediatric Nephrology) Rochester, Minnesota Principal Investigator: Dawn Milliner, MD Contact: Chuck Madsen: E-mail: Madsen.charles@mayo.edu Phone: (507) 266 9391 If you are from Europe please contact: University Children's Hospital (Division of Pediatric Nephrology) Cologne Principal Investigator: Bernd Hoppe, MD Contact: Bernd Hoppe, MD: E-mail: bernd.hoppe@uk-koeln.de Academy Medical Center, University of Amsterdam (Division of Pediatric Nephrology) Amsterdam Principal Investigator: Jaap Groothoff MD Contact: Jasper Jöbsis: E-mail: j.j.jobsis@amc.uva.nl Disclaimer: The OHF Foundation is not an accredited medical institution. It is a non-profit organization committed to raising funds for OHF research. While we are happy to share information from accredited medical professionals, none of the information in this section of the web site is the expressed interest of or a recommended course of action by the OHF Foundation. |
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