Our DCRI team of nephrologists and urologists is committed to advancing clinical trials in all types of nephrology through our vast experience in conducting federally-funded and industry-supported trials and observational clinical research.
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 conducting clinical trials to guide treatment of patients with or at risk for kidney disease. The DCRI Nephrology team's work spans a range of kidney disease, from primary glomerular diseases to diabetic and other forms of chronic kidney disease and stone disease.
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 DCRI-led trial seeks to determine the optimal level of phosphate for patients with end-stage renal disease who are undergoing hemodialysis.
The HiLo trial, led by the DCRI's Myles Wolf, MD, MMSc, is a pragmatic, multicenter outcomes trial that examines the management of phosphate. The trial will provide data on how best to manage hyperphosphatemia, which will improve patient outcomes.
“Poor outcomes in end-stage renal disease are driven primarily by an 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.”
Resuscitation Care May Differ for Patients on Dialysis
A study by nephrologist Patrick Pun, MD, and Monique Starks, MD, used real-world data to reveal opportunities for improvement in the care that patients on dialysis receive after an in-hospital sudden cardiac arrest.
Partnering With Cardiologists to Answer Questions
Nephrologist Daniel Edmonston, MD, chatted with cardiologists Robert Mentz, MD, and Neha Pagidipati, MD, MPH, about how their work intersects when conducting research and caring for patients.
Two studies in which the DCRI is involved are focused on prevention and treatment of kidney stones. One of the studies is testing the hypothesis that increasing hydration via a smart water bottle could result in fewer kidney stones.
EMPA-KIDNEY examines the effects of empagliflozin in CKD patients with and without diabetes
Via a partnership with the University of Oxford, the DCRI is investigating 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. Empagliflozin has traditionally been used to lower glucose in patients with diabetes, but this study includes both patients with and without diabetes to learn more about the drug's effect on 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.
Interested in a Nephrology Research Fellowship?
The DCRI is committed to training fellows and junior faculty in order to develop the next generation of clinical researchers.
Learn how you can become part of the Nephrology Research Fellowship Program and work directly with faculty members on a wide range of nephrology research.
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.