September 8, 2011
By Ryan McBride
A multi-organizational effort to combat polycystic kidney disease has turned to the scientists at software and consulting firm Pharsight to develop quantitative models of the disorder. It’s another step in the Critical Path Institute’s PKD Consortium quest to advance CDISC research data standards and an imaging biomarker for the kidney disease, which affects one in 500 Americans and more than 12 million people worldwide.
The group wants to develop the imaging biomarker, known as total kidney volume (TKV), and gain the FDA’s support for the marker as a key measurement of autosomal dominant polycystic kidney disease in clinical
trials for drugs against the genetic condition. Toward that end, Pharsight and the PKD Consortium aim to create a disease-progression model with data collected from studies of the ailment “that will evaluate the relationship between TKV and the known complications of ADPKD, including rate of loss of kidney function, development of end-stage renal disease and mortality,” Pharsight said in a release.
“This is a very exciting project that leverages the power of collaboration,” said Dr. Eslie Dennis, executive director of the PKD Consortium, in a statement. “Traditional endpoints of renal function only show
changes very late in the course of the disease, making it difficult to assess the effectiveness of new medications. There is critical need for a biomarker that will assess disease progression at an earlier stage when patients may be more likely to respond to new therapies.”
The groups involved in the consortium also include the PKD Foundation, a financial supporter of the effort, the Clinical Data Interchange Standards Consortium (CDISC), as well as experts from Emory University, the Mayo Clinic, Tufts University and the University of Colorado, Denver.