Emory University Hospital is one of a handful of sites across the country currently participating in a clinical trial to study a new treatment for acute renal failure (ARF), a life-threatening condition that affects as many as five percent of hospitalized patients in the U.S.
Nephros Therapeutics, Inc, sponsor of the clinical trial, has started enrolling initial patients to assess the company's Renal Bio-replacement Therapy (RBT¿) for the treatment of acute renal failure. ARF is a critical condition which often leads to Multi-organ failure, severe inflammatory disease, high mortality and extensive hospital stays.
"Nephros' RBT is designed as a transitional therapeutic intervention to provide replacement of essential biologic kidney function," says James Tumlin, MD, associate professor of internal medicine at Emory University School of Medicine.
Acute renal failure in conjunction with multiple organ failure is a serious, life-threatening condition. Approximately 667,000 patients developed ARF in the U.S. in 2001. "The most critically ill ARF patient segment is growing seven to nine percent per year. Factors that predispose to ARF include diabetes mellitus, atherosclerosis, advanced age, and previous cardiac or vascular surgery, all of which are on the rise," explains Dr. Tumlin.
The multi-center, randomized controlled trial is expected to enroll 100 patients at leading medical centers across the United States and began at Emory University Hospital under the direction of Dr. Tumlin. The Phase II clinical study is expected to be complete in early 2005.
"Acute Renal Failure, multi-organ failure and associated severe inflammatory states present serious life-threatening conditions with few satisfactory treatment options," says Dr. Tumlin. "We are excited about the opportunity to participate in this trial and are hopeful that Nephros' Renal Bio-replacement Therapy will reduce mortality which is reported to be as high as 50-70 percent in this group of patients with ARF."
A multi-center, randomized controlled trial of the RAD has recently been initiated and is expected to enroll 100 patients at leading medical centers across the United States. Under the direction of Dr. Tumlin, Emory University Hospital is the leading enroller in the study and has successfully treated patients with the device for up to 72 hours. The Phase II clinical study is expected to be complete in early 2005.
Clinical sites participating in the trial include The Cleveland Clinic, The University of Maryland and The University of Chicago, with additional sites at leading academic medical centers being added across the United States.