Joseph A. Vassalotti MD - Renal and Urology News

Ask the Experts – Joseph A. Vassalotti, MD

Expert Perspective
Highlights From the National Kidney Foundation 2020 Spring Clinical Meetings

Joseph A. Vassalotti, MD

Practice Community: New York City

Hospital and Institutional Affiliations: Clinical Professor, Icahn School of Medicine at Mount Sinai, and Chief Medical Officer, National Kidney Foundation, both in New York City.

Practice Niche: Nephrology

In response to the COVID-19 pandemic, the National Kidney Foundation (NKF) for the first time in its history had to cancel its in-person Spring Clinical Meetings, which had been scheduled to convene in New Orleans. Instead, NKF converted that meeting into a live-virtual conference. Scheduled speakers gave video presentations remotely. Dr Vassalotti, NKF’s Chief Medical Officer, moderated a late-breaker abstract session. Renal & Urology News asked him for his takeaways from the Spring Clinical Meetings.

Question 1. What would you like to highlight from the meeting?
Answer
The most important and remarkable aspect of the remote 2020 meeting is that it was convened for the first-time ever with only 2 weeks’ notice of the transition from a face-to-face meeting in New Orleans to the virtual format. This required a remarkable and unprecedented effort on the part of the faculty, Program Chair Dr Mark Perazella, and NKF staff to transform 130 sessions that were remarkably well attended. I am inspired by the effort that was expended, particularly by 338 faculty presenters, some of whom were living and working in the midst of a local outbreak of the COVID-19 pandemic. There were over 3500 participants overall, with over 1200 for Dr Holly Kramer’s NKF Presidential Address that called on the interdisciplinary attendees to awaken the kidney giant within each of us. We are a community that is not afraid to disrupt the status quo to advance clinical care, clinical research, and advocacy.

Another highlight, given the current COVID-19 pandemic, was the special addition to the meeting titled, “COVID-19 Disease Information for Dialysis Providers,” particularly since it drew upon the early outbreak experience from Seattle. It featured presentations by Dr Suzanne Watnick, Chief Medical Officer of Northwest Kidney Centers, and Dr Shannon Novosad, a CDC Epidemic Intelligence Science Officer. They provided a timely and extremely useful description of the epidemiology of the COVID-19 outbreak, practical recommendations in the context of local experience for the outpatient dialysis clinic, and useful resources from CDC and other health authorities.
Question 2. Two of the late-breakers in the session you moderated showed that voclosporin and difelikefalin are effective therapies for lupus nephritis and CKD-associated pruritus, respectively. In your opinion, would these therapies be game changers, and why?
Answer
These are promising new therapies, but I think calling them game changers is premature. Voclosporin versus placebo recipients in the AURORA phase 3 trial1 were 2.65 times more likely to meet the criteria for response based on proteinuria and eGFR for patients with lupus nephritis. But voclosporin was used as an add-on therapy to mycophenolate mofetil and steroids in patients with proteinuria and mean normal kidney function. Thus, voclosporin is an incremental advance in this specific lupus nephritis subpopulation.

The placebo-controlled difelikefalin phase 2 study2 was of an oral formulation that shows promise for pruritus in CKD patients. The oral formulation’s role in treating pruritus in CKD patients not treated with dialysis will require further study. Diagnosis of the cause of pruritus is worth emphasizing, since uremic etiology is unlikely to uniformly be attributable in this population with a broad range of kidney function. Previously, an intravenous formulation had shown promise in hemodialysis patients.3
Question 3. What are your thoughts about the BETonMACE study, which you wanted to include in the late-breaker session but the investigators declined to present?
Answer
This study is important because it supports an intervention that may be protective for recurrent cardiovascular events in the population with type 2 diabetes mellitus and CKD after an acute coronary syndrome. Cardioprotective therapies are important to emphasize for this group of patients, which experience high rates cardiovascular events and mortality. In patients with CKD, expanded MACE (cardiovascular death, nonfatal myocardial infarction, stroke, and hospitalization for congestive heart failure) occurred in 12.9% of apabetalone patients compared with 25% of placebo recipients, for a 52% decreased risk of expanded MACE.4
Question 4. Five metabolic acidosis-related studies were presented at the meeting. Among other findings, they revealed that metabolic acidosis is undertreated in CKD, it predicts all-cause mortality in CKD, and it is common in patients with hyperkalemia. What do you make of these findings? How should these findings influence how clinicians think about the condition?
Answer
Metabolic acidosis is a complication of CKD, and is particularly common when the eGFR is less than 30 mL/min/1.72m2. Given that metabolic acidosis is typically seen with advanced or low levels of kidney function, associations with other CKD complications such as hyperkalemia, anemia, mineral and bone disease as well as mortality make conceptual clinical sense. What is important about CKD metabolic acidosis is that several real-world studies have shown undertreatment, even by nephrologists, and that accumulating data indicates alkali therapy versus placebo improves a number of outcomes, including slowing the loss of eGFR, improving muscle function, and enhancing bone health. Targeting a response based on the serum total CO2 to a level of approximately 22-24 mEq/L is feasible in clinical trials and should be in practice. These abstracts should serve to increase detection and improve management of CKD metabolic acidosis.
Question 5. In general, based on studies presented at the conference, do you think we are entering a new era in kidney care in which patient quality of life is given greater consideration than in the past?
Answer
I think we are working to establish a new era, wherein the patient voice plays a role in education, care delivery, advocacy, and research. On July 10, 2019, the announcement of the Presidential Order Advancing American Kidney Health Initiative took the largest steps forward in US kidney care since the end-stage renal disease program began in 1973. Although the progress of this initiative was necessarily delayed by the COVID-19 pandemic in time leading up to the conference, the NKF is working to ensure that the goals of the initiative are ultimately realized, including decreasing kidney failure and promoting patient-centric therapies, home dialysis and kidney transplantation. At the NKF Spring Clinical Meetings, the role of the patients with kidney diseases has expanded to include not only audience participation, but engagement as speakers, particularly for multidisciplinary sessions. Also at the 2020 meeting, the fourth Celeste Castillo Lee Patient Engagement Award was announced. It is the highest honor given by the National Kidney Foundation to a distinguished kidney patient who exemplifies NKF’s mission and Celeste’s legacy of putting patients at the center of all aspects of healthcare through their involvement with NKF and community partners. Erich Ditschman received the award in 2020 for his exceptional, tireless advocacy and peer mentorship for kidney patients.5

Reference

  1. Gibson K, Parikh S, Sexena A, et al. AURORA phase 3 trial demonstrates voclosporin statistical superiority over standard of care in lupus nephritis (LN). Abstract 407.
  2. Yospovitch G, Awad A, Spencer R, et al. Efficacy and safety of oral difelikefalin in stage 3-5 chronic kidney disease patients with moderate-to-severe pruritus: a response analysis from a randomised, placebo-controlled, phase 2 trial. Abstract 409.
  3. Fishbane S, Jamal A, Munera C, et al. A phase 3 trial of difelikefalin in hemodialysis patients with pruritus [published online November 8, 20190. N Engl J Med. 2020;382-232. doi: 10.1056/NEJMoa1912770.
  4. Kalantar-Zadeh K, Nicholls SJ, Buhr KA, et al. Apabetalone reduces cardiovascular events in patients with chronic kidney disease, type 2 diabetes, and recent acute coronary syndrome: A BETonMACE trial report. Abstract 408.
  5. Celeste Castillo Lee Patient Engagement Award. National Kidney Foundation. Accessed at https://www.kidney.org/spring-clinical/celeste-castillo-lee-patient-engagement-award