Medpace Holdings Inc.

08/14/2024 | Press release | Distributed by Public on 08/14/2024 08:09

Highlights and Innovations from the 2024 ERA Congress

In May 2024, Medpace nephrology medical and operational experts attended the 61st ERA (European Renal Association) Congress in Stockholm, Sweden. Learn more from Dr. Ajay Srivastava, Senior Vice President Medical Department, Dr. Ineta Sosare, Medical Director and Frenel Joseph, Senior Director, Clinical Trial Management, as they recap highlights from ERA 2024.

ERA 2024 Global Overview

As one of the largest congresses in the field of nephrology and renal diseases, the ERA Congress spanned topics such as chronic kidney disease (CKD) including especially glomerular diseases, acute kidney injury (AKI) & critical care, end stage kidney disease (ESKD) & renal replacement therapy (RRT), kidney transplantation, and general nephrology - especially in relation to clinical trials, including highlights and late-breaking studies.

It is a great opportunity for people with various backgrounds and interests to learn about current industry topics while experiencing endless networking opportunities and fun activities.

The 4-day congress which took place in Stockholm, Sweden this year drew approximately nine thousand in-person and virtual attendees. On the first day itself, it featured a large variety of scientific and industry sessions, along with informative abstract lectures and a well-organized opening ceremony introduced by HRH Prince Daniel, Duke of Västergöland member of the Swedish royal family.

The Medpace team had an opportunity to connect with a number of talented individuals including past, current, and future nephrologists, patient advocacy groups, clients, collaborators, and friends.

Key Conference Takeaways

This year's congress covered many current industry topics including KDIGO updates, C3GN, SGLT2 inhibitors, IgA Nephropathy (IgAN), clinical biomarkers, chronic cardiovascular-kidney-metabolic disorder, multidisciplinary approaches to therapy optimization, and renoprotection in people with metabolic syndrome.

IgA Nephropathy

In the field of glomerular diseases, notable progress has been made in managing and targeting the complex pathophysiology of IgAN, also known as Berger disease.

The landscape of clinical trials in IgAN has exploded over the past decade. From the 1990's to 2015, there was very little traction in trials of steroids or non-specific immunosuppression. Incredibly however, in just the past 5 years, there have been approximately 20 drugs in clinical development and new therapies now specifically approved for the treatment IgA Nephropathy.1

Recent advancements include two new products, Nefecon and Sparsentan, and there is great interest in the nephrology community as to how these new treatments will evolve the management of those with IgAN. Given the current landscape in conjunction with standard of care maintenance therapies, these developments engender questions about the duration and long-term effects of treatment and the potential implications for combination therapy. These recent and ongoing trials are helping to shift the treatment paradigm in the management of the most common glomerulonephritis in the world.

SGLT2i (Sodium-Glucose Cotransporter-2 Inhibitors)

Initially introduced for type 2 diabetes, SGLT2i's have also shown significant benefits for treating chronic kidney disease. Large clinical trials such CREDENCE, DAPA-CKD or EMPA-KIDNEY have established that SGLT2i's induce a renoprotective effect (Figure 1).

During the ERA congress in May 2024, there were ample talks, presentations, and late breaking sessions which represented the increasing consensus on the renal benefits of this therapy, and therefore moving this class of drug into a new era of transforming kidney health. For CKD patients who are at increasing risk of progression dependent on the underlying disease and severity of the underlying kidney dysfunction, SGLT2i's are reported to reduce: the risk of serious acute kidney injury, the need for renal transplantation in patients with or without diabetes, and the rate of eGFR decline (Figure 2).

SGLT2i's are therefore poised to become a standard of care for patients with CKD to reduce cardiorenal risk. As such, the early identification and treatment of high-risk CKD patients may spare these individuals the need for dialysis during their lifetime.

[Link]Figure 1: Large SGLT2i CKD Progression Trials
(Click to expand)
[Link]Figure 2: SGLT2i Clearly Reduce risk of Kidney Failure
(Click to expand)

Clinical Trials of the Future: A Forward-Thinking Community

The conference provided a forum for thorough discussions on the state of clinical trials for the future in the nephrology space. The discussions emphasized the need for healthcare insurers, regulators, clinicians, patients, advocacy groups, and industry to align their visions on key diseases for study. A resounding message was that key stakeholders should aim to be congruent on several important considerations in order to optimize future clinical trials which included: the value of conducting randomized clinical trials in the earlier stages of CKD; Evaluation and re-evaluation of current endpoints (including surrogate), biomarkers/immunomarkers and the development of novel ones; Major barriers to enrollment in clinical trials and ultimately disease management.

Many more exciting topics were discussed at the ERA Congress this year. Medpace is looking forward to the 2025 meeting in Vienna, as well as additional upcoming conferences in nephrology and renal diseases.

[Link]Dr. Ajay Srivastava, Senior Vice-President, Medical Department at Medpace contributes to the discussion regarding surrogate endpoints in kidney disease.

An Industry Leader in Nephrology Clinical Research

Medpace has built a team of therapeutically-aligned operations and regulatory experts who work collaboratively with and alongside our specialized medical team to manage and execute nephrology trials encompassing Sponsor/CRO project management and site study coordination from the patient care perspective. A best-fit, cross-functional team is assigned to each project upon initiation, and typically remains in place through trial completion, producing truly seamless drug development.

Interested in learning more? We welcome the opportunity to discuss your upcoming clinical development in nephrology and renal diseases. Contact our nephrology and renal diseases experts today.

References

  1. Rizk, D. V. (2022). The Rapidly Changing Landscape of IgA Nephropathy Treatment. Kidney News, 14(12), 23-23. Retrieved Jun 21, 2024, from https://www.kidneynews.org/view/journals/kidney-news/14/12/article-p23_20.xml