Two-Day Workshop Presents Data on Use of Earlier Markers of CKD Progression
In mid-March, the National Kidney Foundation, in collaboration with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), concluded a scientific workshop to review the results of a major, multi-year meta-analysis designed to examine the “largest compilation of data ever collected on chronic kidney disease (CKD),” according to a press release from the National Kidney Foundation. The groups reviewed data supporting the use of earlier markers of progression of CKD as end points in clinical trials for early stages of kidney disease. It is hoped that the clinical trials will ultimately lead to improvement in the lives of people with CKD. The meta-analysis included data on nearly two million participants.
The joint workshop was titled Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of Chronic Kidney Disease. Results of the analysis were presented along with recommendations on whether surrogate biomarkers (albuminuria, changes in the rate/slope of glomerular filtration rate [GFR] decline, and GFR and albuminuria in combination) can serve as predictors of the effects of treatments on progression to kidney failure in clinical trials in early stages of CKD.
Kerry Willis, PhD, chief scientific officer at the National Kidney Foundation, said, “This extensive meta-analysis of end points for chronic kidney disease builds upon previous research which recommended a 30% or 40% decline in GFR as the end point for clinical trials in some CKD populations. However, we’ve found that these recommended end points are less applicable to the clinical development of drugs targeted at earlier stages of kidney disease and for many drugs with possible hemodynamic effects. How to overcome these obstacles was the driving force behind today’s scientific workshop and this multi-year research project.”
The meta-analysis included data from more than 49 randomized clinical trials representing 44,816 patients. A second part of the analysis included data from a consortium of international observations cohorts; urine protein was evaluated in 19 cohorts with 600,000 participants and GFR slopes were analyzed in 22 cohorts with 1.3 million participants. The research was conducted at Tufts Medical Center in Massachusetts, Johns Hopkins University in Maryland, the University of Utah, and Groningen University, in The Netherlands.
Andrew S. Levey, MD, professor of medicine at Tufts University School of Medicine, served as the chair of the workshop. “For more than two years, some of the world’s leading researchers have complied and analyzed extensive data which will be useful in both clinical practice and future clinical trials for kidney disease. The work presented over the past two days will help us move closer to developing medications to arrest kidney disease in its earliest stages before patients progress to end-stage renal disease and are faced with life-threatening complications and only dialysis or a transplant as options to survive,” Dr. Levey said.
The workshop, held March 15-16, included 150 stakeholders, including study investigators who contributed data for the analysis, representatives from the FDA, EMA, National Institutes of Health, Centers for Medicare & Medicaid Services, clinical trial and laboratory experts, professional associations and guidelines groups, researchers in the pharmaceutical industry, and patients affected by CKD. The initiative was supported by grants to the National Kidney Foundation from: Alexion, Astellas, AstraZeneca, Aurinia, Bayer, Boehringer-Ingelheim, Calliditas, Gilead, Ironwood, Janssen, Kyowa Hakko Kirin, Merck, Novartis, Novo-Nordisk, Reata, Retrophin, and Tricida.
Robert Provenzano, MD, Recipient of Distinguished Nephrology Service Award
At the 2019 Annual Meeting of the Renal Physicians Association in Orlando, Florida, in March, Robert Provenzano, MD, FACP, FASN, received the Distinguished Nephrology Service Award. Dr. Provenzano is the chief medical officer for Nephrology Practice Solutions and vice president of medical affairs for DaVita Kidney Care.
In a press release from DaVita, Dr. Provenzano said, “It’s a privilege to be recognized by my peers with this honor. I’m grateful to have worked alongside many of you throughout my career as we’ve strived to care for patients with kidney disease and help them live better quality lives.”
The award is given to a member of the Renal Physicians Association who has “contributed to nephrology in the field of socioeconomics or clinical practice, and who has largely impacted the clinical care of kidney patients,” according to the press release.
Allen R. Nissenson, MD, FACP, chief medical officer for DaVita Kidney Care and past president of the Renal Physicians Association, and previous recipient of the Distinguished Nephrology Services Award, said, “This is a well-deserved celebration of Dr. Provenzano and his professional accomplishments. We’re incredibly proud of him and the work he has done to benefit patients both at DaVita and within the larger kidney care community.”
Dr. Provenzano has been a member of the Renal Physicians Association for more than 25 years and has served as president and councilor. He joined DaVita as vice president of medical affairs in 2004, and in 2014 he became the chief medical officer of Nephrology Practice Solutions, a national kidney care management company affiliated with DaVita. He is also a clinical professor of medicine at Wayne State University School of Medicine in Detroit.
Successful ESCO Management Subject of Panel Discussion at RPA Meeting
Physician practice managers from Louisiana, Tennessee, North Carolina, and South Carolina took part in panel discussion at the Renal Physicians Association Annual Meeting in March to address the launch of End-Stage Renal Disease Seamless Care Organizations (ESCOs) in their states. The discussion was part of the Business Management Track at the meeting.
The panel included Mary Alice Stanford, MBA, CMPE, executive director of Renal Associates of Baton Rouge LLC; David Arrieta, MBA, CMPE, of Nephrology Associates, Nashville; Jennifer Huneycutt, CPA, CMPE, executive director of Metrolina Nephrology Associates, Charlotte; and Carole Ann Norman, Columbia (SC) Nephrology Associates.
The panel agreed that organization is a key component in successfully launching an ESCO, and offered details about the workloads required to manage and help direct patient care. They noted that the nephrologist is crucial to drive results related to patient care. Strong relationships between dialysis center management and staff are also important, in addition to relationships with hospital managers and hospitalists, the panel agreed.
Survey of Nonadherence in Patients with Kidney Failure Results
Results of a nationwide survey released in March demonstrated that patients 18 to 39 years of age with kidney failure are more likely to struggle with their prescribed treatment regimen than are older patients. The younger patients also reported feeling depressed nearly twice as often as patients ≥40 years of age.
The survey was administered by the American Kidney Fund (AKF) and included responses from 1200 dialysis patients who have received financial grants from AKF, as well as 400 renal professionals, including ~250 dialysis social workers. Results were reported in a press release from AKF.
LaVarne A. Burton, president and CEO of AKF, said, “The treatment regimen for people living with kidney failure is complex and demanding, yet following the prescribed treatment plan is essential for patients to have the best health outcomes possible. Living with kidney failure is enormously challenging for patients, and we want this survey to foster a deeper understanding of patient experiences and challenges so that the entire renal community may more effectively support patients.”
Topline findings include 30% of patients overall reporting leaving dialysis sessions early and 18% saying they skipped sessions altogether; among patients 18 to 49 years of age, 50% left sessions early and 30% said they skipped sessions altogether. When asked about depression, younger patients reported higher rates of debilitating feelings of sadness than patients ≥40 years of age.
The report, titled Barriers to Treatment Adherence for Dialysis Patients, was funded by a grant from Amgen. AKF conducted the survey to determine how widespread nonadherence is among dialysis patients, as well as factors that make it difficult for patients to follow their treatment plans and interventions to help patients improve their treatment self-management.