Our DCRI team of nephrologists and urologists has years of collective experience in conducting federally-funded and industry-supported trials and observational clinical research. Backed by the unparalleled clinical research infrastructure at DCRI, we are ideally positioned and committed to advance clinical trials of all types in nephrology.
Myles Wolf, MDInterim Director, DCRI Nephrology
"Multicenter clinical trials are desperately needed to define optimal approaches to management of patients across the continuum of kidney disease."
Chronic Kidney Disease:
Global Health Threat
Chronic kidney disease is a global public health threat that confers high risks of end-stage renal disease, cardiovascular disease and premature death. Historically, nephrology and urology have trailed other areas in its use of clinical trials to guide treatment of our patients with or at risk for kidney disease. Multicenter clinical trials are desperately needed to define optimal approaches to management of patients across the continuum of kidney disease, from primary glomerular diseases to diabetic and other forms of chronic kidney disease and stone disease; and for patients with early and intermediate stages of kidney disease to those undergoing dialysis and following kidney transplantation.
DCRI Nephrology offers end-to-end services rooted in basic science and expertise in a broad array of clinical study types that allow for streamlined execution of trials. We make use of DCRI’s data coordinating center expertise and best-in-class statistics, informatics, biomarkers, operations, health services research (outcomes), and communications teams. Our work also benefits from:
- Practicing physicians grounded in the realities of contemporary clinical care
- Collaboration between nephrology and urology
- Experienced operational teams and ARO infrastructure
- An extensive and engaged site network
- Access to a state-of-the-art Early Phase research unit for first-in-human studies
- Availability of diverse patient populations
- Relationships with DCRI’s Cardiovascular/Metabolic faculty to support bidirectional enrichment of design and analysis of kidney and cardiovascular trials
HiLo trial aims to define optimal serum levels in renal disease patients
A new trial led by the DCRI seeks to answer the question of what is the optimal level of phosphate for patients with end-stage renal disease who are undergoing hemodialysis.
The HiLo trial, led by Myles Wolf, MD, MMSc, is a pragmatic, multicenter outcomes trial that compares management of phosphate to either higher or lower serum phosphate targets.
“Poor outcomes in end-stage renal disease are driven primarily by increased risk of cardiovascular disease and hyperphosphatemia is thought to contribute,” Wolf said. “Yet guidelines for how to best manage hyperphosphatemia are based on expert opinion rather than clinical trial data. For decades, we’ve inferred the need to lower serum phosphate from observational and pre-clinical studies, but we never proved if our approach is or is not helping patients.”
“By embedding rigorous research into clinical care delivery, HiLo addresses a question of great importance to patients and clinicians,”said the University of Pennsylvania’s Laura Dember, MD, a member of the HiLo Steering Committee.
CPR rates low in dialysis clinics
A study by DCRI researchers found that CPR performed by dialysis clinic staff was associated with a three-fold increase in odds of survival to hospital discharge.
How diet may affect chronic kidney disease
The DCRI’s Julia Scialla, MD, MHS, is a Duke Health Scholar whose work focuses on how unhealthy diets can exacerbate the symptoms of chronic kidney disease.
Preventing kidney stone recurrence
Researchers with the Prevention of Urinary Stones with Hydration (PUSH) study are trying to determine whether using a high-tech water bottle and encouraging people to drink more water will reduce the recurrence of kidney stones.
EMPA-KIDNEY will study the effects of empagliflozin in CKD patients with and without diabetes
The DCRI will partner with the University of Oxford to investigate the effects of empagliflozin (sold under the brand name Jardiance) on the progression of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease.
“We need to explore new treatment options that can help slow the progression of chronic kidney disease, given that 30 million adults in the United States are living with this condition,” said Jennifer Green, MD, endocrinologist and associate professor of medicine at the DCRI, which is responsible for U.S. trial operations. “The EMPA-REG OUTCOME trial findings prompted us to explore further the effects of empagliflozin on the risk of new or worsening kidney disease in adults with type 2 diabetes and established cardiovascular disease. Now, EMPA-KIDNEY will examine whether empagliflozin has the potential to be a new treatment option for people with chronic kidney disease.”
Nephrology Leadership at the DCRI
Myles Wolf, MD, MMSc, is Interim Director of the Nephrology Therapeutic Area at DCRI. He is Professor of Medicine and Chief of the Division of Nephology in the Duke University School of Medicine.
Dr. Wolf uses a combination of patient-oriented studies, population-based epidemiological studies, clinical trials, and laboratory-based studies in his multidisciplinary translational approach. His research focuses on disordered mineral metabolism across the spectrum of chronic kidney disease, including dialysis, kidney transplantation and earlier stages.
Dr. Wolf has extensive experience in clinical trial design and execution, including traditional NIH-supported trials (e.g., the COMBINE trial), pragmatic NIH-supported trials (e.g., the HiLo trial) and industry-sponsored trials (e.g., the FIRM trial). His research has been published in leading general medicine and subspecialty journals, including the New England Journal of Medicine, JAMA, the Journal of Clinical Investigation, Circulation, Cell Metabolism, the Journal of the American Society of Nephrology, and Kidney International, among others.
Partnerships That Benefit Patients
The Urinary Stone Disease Research Network (USDRN) is a group of scientists and investigators designing and conducting research on urinary stones (kidney stones) in adults and children in order to learn more about who forms kidney stones, what are the best treatments, and how to prevent stones from forming.
Funded by the National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the network comprises a wide range of experts including adult and pediatric urologists, adult and pediatric nephrologists (kidney specialists), pediatricians, emergency department physicians, clinical trialists, nutritionists, behavioral scientists, and radiologists. The DCRI is the USDRN Scientific Data Research Center.