Thursday, November 13, 2014YOUNGSTOWN, Ohio -- A Canfield physician and a Youngstown State University professor will jointly conduct a clinical drug study funded by a global pharmaceutical firm, YSU Interim Provost Martin Abraham announced Wednesday.
At a press event at YSU, Abraham presented Erdal Sarac, M.D., medical director at the Centers for Dialysis Care in Canfield, and Jane Wetzel, Ph.D., assistant professor of physical therapy at YSU.
They will use the Mallinckrodt Pharmaceuticals grant of more than $70,000 to determine the effect of H.P. Acthar Gel on how the kidney functions in someone with end-stage renal disease, on that individual’s nutrition, how it affects his quality of life and his ability to perform physically.
“This is the first time YSU’s going to be participating in a clinical drug study,” Abraham said, pointing out that the grant is the latest in a series of firsts for the university regarding research opportunities.
The study, “Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population,” grew out of research Sarac began and conducted last year with Wetzel under a $5,000 grant from the Medical Research Council at St. Elizabeth Youngstown Hospital.
The earlier study examined the baseline characteristics of patients on dialysis from a biochemical standpoint and correlated that with their physical performance, Sarac said. “I started thinking about whether there is a way to improve [patients’ health based on] these findings and help these patients achieve better physical performance and feel better on dialysis,” he continued. He came across the gel as a potential agent that could help people on dialysis agent and applied to the pharmaceutical company for an investigator-initiated study. Mallinckrodt approved his proposal.
Sarac, also a professor of internal medicine at the Northeast Ohio Medical University and a practicing nephrologist at St. Elizabeth Youngstown, will recruit the patients needed for the study. It requires 30 patients not suffering from diabetes and have been on dialysis for less than five years.
“That drug is going to stimulate the adrenal gland and then that stimulation will go forward to help the patients’ kidney functions to a degree where they don’t spill out protein,” Wetzel said. “Protein will then build muscle mass and overall nutrition will go up as well.”
As sponsor of the study, YSU will administer the finances and coordinate it, “making sure that all of the patients receive the communication about what the study’s about,” Wetzel said, and organize the data. The physical therapy department will perform various tests related to areas such as body composition, strength and gait speed. YSU will subcontract with St. Elizabeth Youngstown to perform lab work.
Participants in the study will be assessed at the start to get baseline measures, then be reassessed at three and six months for both renal and physical functions to determine the levels of improvement in those parameters with the use of the medication.
“The primary goal is to improve the well-being of the patients,” Sarac said. “If we can improve muscle strength, nutrition and some of the measures that Dr. Wetzel is going to measure … I think that will make a positive impact on how the patients feel on dialysis and off dialysis.
“Now, if the drug also makes a positive impact on renal function and we have improved urine output and clearance by their own kidneys because of the additional drug, that’s going to be an additional benefit,” he continued. “If it makes any additional effect on the complications of kidney failure such as anemia [and] bone disease, we will be looking at those too and trying to understand that part of the effect of the drug.”
Pictured: Erdal Sarac, M.D., medical director at the Centers for Dialysis Care in Canfield, and Jane Wetzel, Ph.D., assistant professor of physical therapy at YSU.
Copyright 2014 The Business Journal, Youngstown, Ohio.
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