Grant for clinical drug study a first for YSU

A global pharmaceutical company has awarded over a $70,000 research grant to a local physician and a Youngstown State University professor to conduct a clinical drug study aimed at evaluating the impact a drug treatment may have on patients with chronic kidney disease who have been on dialysis for less than five years.

It is the first grant of its kind for YSU and the first time that YSU will be principally involved in a clinical drug study.

“This grant, and the work that will be done on campus as a result, is yet another indicator of YSU’s continued evolution into a research university of growing prominence,” Martin Abraham, interim provost, said at a news conference this morning on campus to announce the grant and study.

The grant from Mallinckrodt Pharmaceuticals to Erdal Sarac, MD, medical director at the Centers for Dialysis Care in Canfield, Ohio, and Jane Wetzel, PhD, associate professor of Physical Therapy at YSU, will fund a study to evaluate the impact H.P. Acthar® Gel may have on kidney function, nutritional status, quality of life and physical performance for people with end stage renal disease.

The idea for the clinical study came from Sarac and is an outgrowth of research that he initiated and conducted last year with Wetzel under a $5,000 grant from the Medical Research Council at St. Elizabeth Health Center. The results of that study were presented at the National Kidney Foundation Spring Clinical Meetings earlier this year in Las Vegas.

“It is well known that people with end stage renal disease who undergo dialysis have decreased strength and poor physical functioning that place them at risk for falls, hospitalization and mortality,” said Wetzel, who came to YSU in 2009 after earning a PhD in Exercise Physiology from the University of Pittsburgh. “We hope to determine what impact Acthar Gel can have to decrease those risks.”

In addition to Wetzel and Sarac, Suzanne Giuffre, associate professor of Physical Therapy, and Rachael Pohle-Krauza, associate professor of Human Ecology, are involved in the study.

Under the study titled “Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population,” about 30 non-diabetic subjects who have been on dialysis less than five years will receive varying dosages of the drug. They will then be evaluated every three months for kidney function, nutritional status and physical performance. The studies are to begin this month and will take two to three years to complete.

Sarac, also medical director at Fresenius Medical Care in Salem, Ohio, and a professor of Internal Medicine at the Northeast Ohio Medical University, said the study could result in further collaborations with YSU. “There are always new ways we can find to work together,” he said.