The National Kidney Foundation participates in research that is helping advance knowledge about chronic kidney disease, treatment and patient outcomes. The foundation does this through three major initiatives: the Kidney Early Evaluation Program (KEEP), the Awareness, Detection and Drug Therapy in Type 2 Diabetes Mellitus and Chronic Kidney Disease Study (ADD-CKD) and the Chronic Kidney Disease Prognosis Consortium.
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GFR Decline as an Endpoint in Clinical Trials for CKD
The U.S. Food and Drug Administration (FDA) is now considering new endpoints for clinical trials in chronic kidney disease patients as a result of a special scientific workshop convened by the National Kidney Foundation (NKF) and the FDA on December 3-4 in Baltimore. After extensive analysis of data from observational cohorts and interventional trials, the workshop planning committee and attendees recommended a 30 or 40% decline in glomerular filtration rate (GFR) as new surrogate endpoints for some clinical trials in chronic kidney disease used for regulatory approval.
“While the results will take some time to explore and understand fully, they will provide a firm basis for establishing reasonable end points for studies in chronic kidney disease in the near term. More importantly, the cooperation among regulators, NKF, and academic researchers and the analytical methods developed here should serve as a model to address similar issues in the future,” said Norman Stockbridge, MD, PhD, Division Director, Cardiovascular and Renal Products, FDA.
Chronic kidney disease (CKD) affects 26 million Americans and is a significant public health problem in the U.S., yet its progression is slow and CKD is often asymptomatic until it reaches kidney failure. “Efficiently testing drugs to slow the progression of CKD has been a major challenge, since the beneficial effects of treatment don’t manifest in patients for many years,” said workshop co-chair Andrew Levey, MD, Professor of Medicine, Tufts Medical Center.
Prior to this workshop, halving of GFR, assessed as a doubling of serum creatinine levels, was considered an acceptable surrogate endpoint for the development of kidney failure. “Yet while doubling of serum creatinine is predictive of kidney failure, even this takes a long time to develop. That’s why NKF collaborated with the FDA on this initiative to identify alternative endpoints that could potentially shorten the duration of clinical trials and extend their application to the early stages,” continued Levey.
The NKF/FDA Scientific Workshop, “GFR Decline as an Endpoint for Clinical Trials in CKD” was the result of the year-long efforts of a Planning Committee chaired by Dr. Andrew Levey and Dr. Aliza Thompson of the FDA, and Dr. Josef Coresh, Chair of the Analytic Group. The 130 workshop attendees included clinical trial and epidemiology experts, regulatory representatives from the European Medicines Agency, National Institutes of Health, Critical Path Institute, the FDA; dialysis and pharmaceutical industry representatives; and other professional organizations, including the American Diabetes Association and the Polycystic Kidney Disease Foundation.
*Recorded plenary sessions from Day 1 of Workshop (Webinar Agenda)
*The meeting includes preliminary (unpublished) data to provide objective information. Plans are underway for checking all analyses and completion of peer reviewed publications to be submitted in 2013. Therefore, materials are shared with the following conditions:
- The materials are only to be used for the workshop and furthering your understanding of the presentations and their scientific basis
- The materials cannot be used for the following:
- Publishing papers in any type of forms (original articles, review articles, editorials, letters, etc.)
- Submitting an abstract to scientific meetings using the data in the Databook or presentations
- Detailed databooks are available upon request from the NKF for uses allowed in a non-transferable Distribution Agreement.
- If you would like to use the materials for other purposes, including interim summaries at relevant scientific meetings, you should contact CKD-PC Coordinating Center (firstname.lastname@example.org). This is important since this information will be updated as we update all analyses for publication.
NKF's signature early detection screening program, the Kidney Early Evaluation Program (KEEP®), offers free screenings in cities around the country to anyone at risk for kidney disease--those with high blood pressure, diabetes or a family history of kidney failure. It is the nation's largest and most successful chronic disease screening program and has touched the lives of nearly a quarter of a million Americans since its inception. KEEP screens kidney function through a variety of tests, including blood, blood pressure and urine.
Everyone screened is entered into the KEEP database of over 170,000 at- risk individuals and test results are studied and analyzed to help doctors find ways to improve outcomes and better treat kidney disease in specific populations.
According to Dr. Peter McCullough, Chairman of the KEEP Steering Committee, KEEP has contributed greatly to the advancement of our knowledge concerning chronic kidney disease among Americans. Since the methods of KEEP touch obesity, diabetes, hypertension, kidney, and heart disease, this program is improving the health and awareness of individuals at risk for these common medical problems.
KEEP is expanding its impact through screening special populations and studying the medical samples of participants to search for markers of chronic diseases that will ultimately lead to the development of new tests and therapies for kidney disease. KEEP is also linking its data with other national databases such as the United States Renal Data System (USRDS) to allow for more research on how kidney disease contributes to the overall provision of care.
Diabetes is the leading cause of kidney disease, yet recent studies have found that only half of primary care doctors discuss chronic kidney disease with their diabetic patients. In an effort to estimate the prevalence of chronic kidney disease in adults with type 2 diabetes and examine their care, the National Kidney Foundation launched a multi-site cross-sectional study, Awareness, Detection and Drug Therapy in Type 2 Diabetes Mellitus and Chronic Kidney Disease (ADD-CKD). This research is assessing how chronic kidney disease is being identified and managed in type II diabetic patients, in the primary care setting, using a survey of 10,000 adult patients and their 500 primary care physicians.
According to Lynda Szczech, MD, MSCE, President of the National Kidney Foundation, primary care physicians are the first line of defense against one of the world's top killers. The goal of this study is to increase the awareness and management of chronic kidney disease in diabetic patients.
Using the contributions of leading investigators from 45 studies, this NKF-funded project is creating and analyzing the world's largest dataset about patient outcomes at all stages of chronic kidney disease. According to Dr. Josef Coresh of Johns Hopkins University, one of the project's leaders, chronic kidney disease is a spectrum disease and at each stage, people experience different complications-- from stroke and hypertension to infections and acute kidney disease. This research will examine how these complications impact a patient's prognosis at each stage.
This project is also led by Drs. Paul de Jong and Ron Gansevoort at the University of Groningen in The Netherlands, and Dr. Andrew Levey at Tufts University.