April 3, 2014 – Uptal Patel named pioneer member of the Kidney Health Initiative The KHI is a new private-public partnership designed to speed the implementation of quality research into practical treatments for kidney patients.
Despite the growing number of Americans afflicted with kidney disease, clinical researchers have made relatively little progress in addressing the problem. The DCRI’s Uptal Patel, MD, and other nephrologists from around the country hope to change that with a new project designed to transform the way clinical trials are conducted in the field of nephrology.
The Kidney Health Initiative (KHI) is a private-public partnership that is designed to speed the implementation of quality research into practical treatments for kidney patients. Patel, director of nephrology research at the DCRI, is one of the initiative’s pioneer members on behalf of the DCRI.
“There have been less than 10 drugs for kidney disease approved in the last decade, and there are a number of serious problems that need to be solved collectively,” he said. “The KHI is our response to these problems.”
Chronic kidney disease (CKD) is a growing and largely underrecognized epidemic in the United States, affecting 1 in 9 Americans. Rising rates of obesity, diabetes, and hypertension have contributed to the growing prevalence of CKD and other kidney ailments. This has in turn created a growing burden on the healthcare system; although CKD patients represent only 8 percent of all Medicare patients in the United States, their care is associated with 22 percent of Medicare expenditures. Despite this, research on new treatments for kidney disease has progressed slowly in recent decades. Between 1966 and 2010, there were fewer randomized clinical trials in nephrology than any other field of internal medicine. Many trials that have been completed have been beset by questions about their quality.
To address these concerns, the Food and Drug Administration (FDA) and the American Society for Nephrology created the KHI in 2012. Comprising representatives from patient and health professional organizations, industry, academia, and government agencies, the KHI is intended to provide a forum for scientific collaboration, dialogue with patient groups and others concerned about kidney health. Although the initiative is new, Patel is hopeful that it will soon be making positive changes in the world of kidney research.
“We’ve identified specific projects that typically require input from the different kinds of members who are represented within KHI,” he said. “The hope is that we can advance the dialogue, policies and best practices necessary to foster the development of new therapies for kidney disease.”
Patel and his colleagues in the KHI are particularly interested in identifying specific clinical endpoints of interest for nephrology trials, a goal that researchers have historically found difficult to achieve.
“By bringing together members of the FDA with members of nonprofits, patient advocacy groups, and academia, we can define the outcomes that will be most meaningful for new medical product development and approvals,” he said. “That’s where we really hope to have an impact.”
The DCRI is well suited to such an initiative, Patel said, citing the organization’s deep experience with projects such as the Cardiac Safety Research Consortium, Clinical Trials Transformation Initiative, and the NIH Health Care Systems Research Collaboratory. Those projects are intended to streamline the journey from scientific discovery to patient care, similar to what the KHI hopes to accomplish within the field of nephrology.
“Because of the wealth of experience at the DCRI, I thought it was important that we be involved,” he said. “I think we have a lot to offer.”