The University of Cincinnati will lead a $5.2 million national trial studying removal of both corticosteroids and common immunosuppression treatments from the post-transplant drug regimen for kidney transplant patients.
The Belatacept Early Steroid withdrawal Trial (BEST) seeks to determine if a belatacept-based regimen for post-transplant patients can prevent organ rejection without the harmful side effects posed by corticosteroids and calcineurin inhibitor (CNI) immunosuppressants. Belatacept is a modified version of the drug abatacept, which is used to treat rheumatoid arthritis.
Led by principal investigator and director of UC's division of transplantation E. Steve Woodle, MD, the $5.2 million trial will be carried out at four other transplant centers across the country: University of Wisconsin, University of Minnesota, California Pacific Medical Center and the Christ Hospital in Cincinnati.
The BEST study is the first large, multicenter trial to remove both corticosteroids and CNIs from a patient's drug regimen after kidney transplantation. Both drugs place patients at an increased risk of cardiovascular disease, high blood pressure, high cholesterol and diabetes. Additionally, CNIs have shown toxicity to transplanted kidneys.
"Cardiovascular events like stroke and heart attacks are the top cause of death for both the general population and transplant patients," says Woodle, who also serves as William A. Altemeier Chair in the UC Department of Surgery. "We've previously demonstrated that early steroid withdrawal results in reduced rates of rejection and increased graft survival in transplant patients."