DENVER, Nov. 22, 2010 - New data suggest Acthar may represent a novel pathway for the treatment of proteinuria due to diabetic nephropathy - Diabetic nephropathy represents the most common cause of end-stage renal disease in the U.S. - On November 20 at the American Society of Nephrology (ASN) 43rd Annual Meeting, interim results presented from an ongoing, randomized prospective study conducted independently by James A. Tumlin, MD, at the University of Tennessee College of Medicine Chattanooga indicated that 9 of 15 patients (60%) with advanced diabetic nephropathy who are currently enrolled in the study and have completed or are still undergoing a six month course of treatment with H.P. Acthar ® Gel (repository corticotropin injection) have exhibited a clinically significant decrease in proteinuria and achieved stabilized renal function. Excessive proteinuria, or urinary protein loss, is a known high risk factor for end-stage renal disease (ESRD).Acthar is not currently indicated for the treatment of proteinuria associated with diabetic nephropathy.
"Our interim analysis suggests that Acthar may reduce proteinuria and stabilize renal function in patients with advanced diabetic nephropathy," stated Dr. Tumlin. "The use of Acthar could represent a novel pathway for the management of proteinuria associated with diabetic nephropathy. Given the very limited number of treatments available for these patients, further clinical evaluation of Acthar in patients with diabetic nephropathy is needed."
This is an exploratory, investigator-initiated study -- conducted independently by Dr. Tumlin but sponsored through a research grant from Questcor. The study currently has 15 patients enrolled. These patients have either completed or are still undergoing a six month course of Acthar therapy, and so far 9 have exhibited either a complete or partial response to therapy... Questcor's Press Release -
