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ECMC participates in promising Polycystic Kidney Disease research

BUFFALO, NEW YORK; February 25, 2011-The Erie County Medical Center is one of only approximately 30 centers in the United States and 100 centers worldwide that have been participating in a double-blind (neither patient nor doctor know if patient is receiving a drug or placebo) clinical trial using medication(s) known as vasopressin inhibitors. 

Polycystic Kidney Disease (PKD) is a genetic (inherited) disorder which results in multiple cysts being formed in the kidneys and sometimes other organs such as the liver and lungs.  The disease is inherited in an autosomal pattern (implies that about half the children parented by a person with the disease will be affected).  The progressive enlargement of cysts over time eventually results in the destruction of healthy kidney tissue.  PKD is the most common cause of kidney failure in patients suffering from primary kidney disease. Although substantial progress has been made defining the genetics of the disease, an effective treatment is yet to be discovered to slow the progression of the development of cysts and loss of kidney function. 

Over the last several years, studies undertaken in laboratory animals, which can develop diseases similar to the human condition, have shown that early treatment with compounds known as vasopressin inhibitors had a dramatic impact.  Vasopressin is a normally occurring hormone that regulates the volume of urine produced.  The development of cysts was halted or even entirely prevented if such medications were given very early in the lives of these animals.

Studies have been undertaken in humans over the last few years using a tablet form of a vasopressin inhibitor.  Most centers enrolled 10-20 patients in such studies.  About 1,400 patients were enrolled on a worldwide basis and more than 1,000 will complete the study.  Preliminary results of these studies have shown a strong suggestion that the rate of cyst formation, growth and size-as determined by repeated assessment of the kidney using three-dimensional magnetic resonance imaging (MRI) scanning-is slowed or improved by the agent called Tolvaptan.  Further, renal function as assessed using various biochemical estimates also appears to stabilize or improve.  These preliminary results have stirred the manufacturer, Otsuka Pharmaceutical Company, to continue the study further in a non-blinded fashion so that both the patients and doctors know that the patients are receiving the actual medication.  Nearly all of the Erie County Medical Center patients studied will go forward for another three years with the study. 

Otsuka is also sponsoring an additional research project wherein patients who elect not to join or were excluded from the initial study can be followed sequentially with lab tests, MRIs and clinical observation while receiving only their current medications.  These patients will benefit by having regularly scheduled imaging studies of their kidneys, periodic assessments, laboratory and clinical assessments provided free by the manufacturer.  The company is also entertaining the possibility of another blinded study, in which the patients will be treated with the next generation of the medication.  This preparation is long acting and needs to be taken only once daily and may have fewer side effects. 

"We are pleased to participate in this important study to care for patients with PKD," stated Rocco C. Venuto, M.D., F.A.S.N., Director, Renal and Transplant Services, ECMC, and Professor of Medicine, Director, Nephrology Division, State University of New York at Buffalo.  "Participation in this study is part of the commitment of the Medical Center as it develops a Renal Center designed to be at the cutting-edge of such research and care for patients with this or other forms of kidney disease." 

MORE ABOUT ECMC CORPORATION: The ECMC Corporation includes an advanced academic medical center (ECMC) with 550 inpatient beds and 136 skilled-nursing-home beds, on- and off-campus health centers, over 40 outpatient specialty care clinics and the Erie County Home, a skilled nursing facility.  ECMC is the regional center for trauma, burn care, rehabilitation, and is a major teaching facility for the State University of New York at Buffalo.  Most ECMC physicians, dentists and pharmacists are dedicated faculty members of the University.  More Western New York residents are choosing ECMC for exceptional patient care and customer service provided as a result of its "Culture of Care". 

NEWS CONTACT: Joe Cirillo at 716-898-4300 or jcirillo@ecmc.edu

2/25/2011

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