Studies
While we are happy to share information on current studies and trials that may be of interest to those affected by PH, 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. For more information about any of these studies, please contact the person or institution directly.

Pivotal study is being conducted with Oxabact™ for the treatment of Primary Hyperoxaluria

OxThera today announced that all 42 patients have been enrolled in their pivotal phase II/III study using Oxabact™ for the treatment of Primary Hyperoxaluria. Results from this multicenter study will be presented during Q4 of 2008 and be used to file for licensure in EU, US and the rest of the world.

Oxabact™ consists of a unique intestinal bacterium, Oxalobacter formigenes, naturally colonizing the intestinal tract of most humans with the purpose to degrade oxalate. Previous studies with Oxabact™ have already shown a significant effect in lowering urinary oxalate which in turn leads to a decreased risk of kidney damage. Oxabact™ has been designated orphan drug status in both EU and the US.

The 28 week pivotal study is a randomized, double-blind, placebo-controlled, multi-center study being conducted at eight Primary Hyperoxaluria referral sites in the Netherlands, France, UK, Germany and US.

Jon Heimer, CEO and President of OxThera comments: "After several years of intensive research on Oxalobacter formigenes and Oxabact™, a significant milestone is met with the inclusion of all patients in this pivotal study. A successful outcome will put OxThera in a position to file for licensure and making the product available to treating physicians and patients during 2009 which is very exciting".

For further information, contact: Jon Heimer, CEO, OxThera
Phone no.: +46 761 171 820

View PDF of Press Release

 

Treatment Study for Primary Hyperoxaluria

If you have PH, or know of anyone who has PH, contact us to participate in an NIH-funded FDA approved study of Pyridoxamine. We are trying to decrease oxalate excretion in Primary Hyperoxaluria, which was successful in experimental animals. We need only 8 Subjects over 18 years of age who have good kidney function, who will take the drug and/or placebo for 20 weeks. They do not have to travel, but will collect a number of 24-hour urine specimens, have 2 or 3 examinations, and 2 or 3 blood specimens. They will need to maintain a constant diet for 3 days of each treatment period. They won't have to travel, since the study can be accomplished by mail and with the help of the local physician, who can be recruited after the patient has consented to the study. There is no reward to subjects, except for the knowledge that they are helping to develop a possible treatment for primary hyperoxaluria, that may prevent the need for kidney or liver transplantation.

 

Jon Scheinman, M.D., Professor
University of Kansas Medical Center
Please respond by email jscheinman@kumc.edu
or phone 888-266-5133

 

Altus Pharmaceuticals’ ALTU-237 Enters Phase I Clinical Trials

Altus Pharmaceuticals’ ALTU-237 Enters Phase I Clinical Trial for the Treatment of Hyperoxalurias and the Potential Prevention of Kidney Stone Formation. Read the Press Release

 

International Registry for Primary Hyperoxaluria & Dent's Disease

Because of the rarity of patients, even physicians who specialize in kidney stone disease are likely to see only a few primary hyperoxaluria or Dent's disease patients over the course of a practicing lifetime.

In an effort to address this need for more comprehensive information, an International Registry was established at the Mayo Clinic Hyperoxaluria Center, with funding from the National Institute of Diabetes, Digestive, and Kidney Disorders (NIH). The Mayo Clinic Hyperoxaluria Center is sponsored by the Oxalosis and Hyperoxaluria Foundation. Learn more...

 

The PHOENIX Research Trial
Evaluating Oxalobacter formigenes in Primary Hyperoxaluria (PH)

A research trial to determine the effectiveness and safety of Oxalobacter formigenes treatment in patients with PH Type I and II has started. Patient enrollment has started in the Netherlands, UK and Germany and will be initiated in France and US after Ethics/IRB approvals have been obtained. This trial is being conducted by OxThera, a clinical stage biotechnology company focused on development of treatments for Primary and Secondary hyperoxaluria.

Oxalobacter formigenes is a unique oxalate degrading bacteria normally present in the human gut. This bacterium can use only "oxalate" as its food and therefore it efficiently degrades all the oxalate it can find to obtain energy for its survival. 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 to pull out the extra oxalate being made by the liver of the PH patients. If the bacterium can do this, less oxalate will be going through the kidneys into the urine.

Participants in this study will have an equal chance of receiving Oxalobacter formigenes or a placebo. The duration of the study is approximately 6 months and the study medication is a capsule given orally twice a day every day. Tests of your eligibility will be conducted at the study center. You should always consult your doctor before participating in a clinical trial.

Clinical trial investigators are:

Dr. George Deschenes, Paris, France
Dr. Pierre Cochat, Lyon, France
Dr. Bernd Hoppe,Cologne, Germany
Dr. Sally Hulton, Birmingham, U.K.
Dr. Markus Kemper, Hamburg, Germany
Dr. Dawn Milliner, Mayo Clinic, Rochester, MN, USA
Dr. Patrick Niaudet
Dr. Robert Unwin, London, UK

If you are interested in participating in this trial, please consult with your doctor.

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Disclaimer: The OHF Foundation is not an accredited medical institution. It is a non-profit organization committed to raising funds for OHF research and various OHF programs. While we are happy to share information, 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. The information on this Web site is provided by the OHF Foundation with the understanding that the publisher, authors, and advisors are not rendering medical or professional services. Medicine is a rapidly changing area, and efforts have been made to provide information that is medically correct at the time of initial posting. The material provided should be used only as a general guide and not the ultimate source of information and should not be used to make personal or professional decisions. The OHF shall have neither liability not responsibility to any person or entity with respect to any loss or damage alleged to be caused directly or indirectly by the information presented in this journal/server.