Thousands Of Cats With Kidney Disease Sought For Groundbreaking Clinical Trial

RALEIGH, N.C., May 2, 2013 /PRNewswire/ -- The largest known veterinary clinical trial of its kind with 35 study sites in the United States and Canada is currently evaluating cats with kidney disease to determine if they also have hypertension (high blood pressure). Kidney disease and hypertension often occur together, especially in older cats. Hypertension has been called a "silent killer" and is difficult to diagnose because there are no visible clinical signs in cats.  As in humans, if left untreated, hypertension in cats can lead to serious consequences, including blindness, heart disease, bleeding in the brain, seizures, worsening of kidney disease, and even death.  There are currently no treatments approved by the Food and Drug Administration (FDA) for hypertension associated with kidney disease in cats, so veterinarians must treat this condition with off-label drugs.  This clinical trial, however, is seeking to change that by evaluating a new, easy-to-administer liquid medication for feline hypertension with the goal of gaining FDA approval. 

Study seeks to contribute to future improvements in feline health
This large FDA-regulated clinical trial will likely screen thousands of cats to help provide important evidence-based research that may lead to new insights, treatments, and improvements in patient health.  If feline hypertension is diagnosed and treated early, then irreversible organ damage may be prevented.

"Hypertension is a serious problem that is frequently associated with kidney disease and hyperthyroidism in cats," says Dr. Scott Brown, a veterinarian and researcher at the College of Veterinary Medicine, University of Georgia, who is board certified in internal medicine and specializes in feline hypertension and kidney disease. "We most commonly see it in older cats, typically those over seven years of age.

"This is an important study because feline hypertension is increasingly being recognized in veterinary medicine as a disease process that causes significant morbidity and mortality," Brown adds. "And unfortunately, we don't yet have any FDA-approved medications to treat it."

Participating pet owners benefit from free veterinary care
This veterinary clinical trial offers free medical care for pets, which can be very beneficial during tough economic times.  For participating cats, this trial provides some of the most advanced veterinary care available, including diagnostics and on-going medical evaluations that are conducted by specially trained veterinarians who specialize in feline medicine.  

Geneva Fraser of Vancouver, Washington recently participated in the trial.  "Until I took my oldest cat, Oscar, in for a senior checkup, I didn't even know cats could have high blood pressure," she says.  "When I learned that he qualified for the trial, I was excited to participate.  When you have an older cat, you want to give them the best quality of life possible.  Oscar has been with us for 15 years and I would do anything I could to help make him happy and comfortable."

Fraser adds, "I've told everybody about this study.  The investigator's clinic is an all-feline practice, so it's not a stressful environment for Oscar.  The process was super simple, and recording the data was actually fun because I knew I was doing something to help other cats.  And believe it or not, Oscar actually likes his cat carrier.  I would tell other cat owners to have their veterinarian check their cat's blood pressure, and I encourage anyone to participate."

Patient enrollment criteria
To qualify for the study, cats must:

• Be at least one year old
• Be diagnosed with kidney disease
• Have high blood pressure (need not be diagnosed before being screened for the study)
• Be without severe signs of hypertension (blindness, retinal detachment, nervous system signs)
• Be well enough to participate for up to six months (participation time depends on many factors, but may be from two weeks to six months)
• Not have any other severe uncontrolled diseases
• Meet all other study requirements (which will be explained by the investigator when the cat is evaluated)

Cats that meet all the criteria for the study receive free medical evaluations and diagnostic tests.  If enrolled in the study, cats will receive study medication or placebo, and required monthly exams at no cost.  In addition to free study-specific care, owners of enrolled cats also are eligible to receive monetary rewards, and to have funds credited to their account at their referring family veterinarian.

Veterinary trial sites located across the U.S. and in Canada
This double-blind, placebo-controlled study is sponsored by a major animal health company and is regulated by the FDA.  Expected to run for two to three years, study sites are currently operating in California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Virginia, Washington, and Wisconsin, as well as in Canada.  For more information or to find out if your cat could be a candidate for the study, visit www.MyCatCanHelp.com or call the toll-free number 855-254-3971.

The medication given to cats in the trial may or may not help their condition.  As with all clinical trials and medications, there are risks and benefits, which the clinical investigator will discuss with cat owners prior to enrollment. 

About Visionaire Research & Education
Visionaire Research & Education helps veterinary pharmaceutical manufacturers in their recruitment efforts for clinical trials.  The company is located in Raleigh, N.C. 

Contact: Alice Coram, Visionaire Research & Education, 919.293.0243, ext. 201

SOURCE Visionaire Research & Education