Introduction
Immunoglobulin A (IgA) nephropathy (IgAN) is the most common glomerular disease worldwide, with an estimated incidence of 25 per million adults.1,2 Despite optimized supportive care, some patients fail to achieve disease control and experience progressive deterioration of kidney function.2 IgAN is a leading cause of chronic kidney disease, with 10–40% of patients progressing to end-stage renal disease within 10–20 years of diagnosis.1,2 Although IgAN is characterized by a single histopathologic criterion of predominant or co-dominant IgA deposits on kidney biopsy, its marked heterogeneity of clinical and pathological features is well recognized.3,4 The vast majority of adult IgAN patients coming to medical attention are those with a slowly progressive course, often with already significantly reduced glomerular filtration rate at presentation, mild to moderate proteinuria, persistent microhematuria, and hypertension.5Program Content
Faculty
Dr. Dana Rizk, (University of Alabama at Birmingham, Birmingham, AL)
Dr. Jonathan Barratt, (University of Leicester, UK)
Dr. Vladimir Tesar, (Charles University, Prague, Czech Republic)
Learning Goals/Purposes
The goal of this project is to provide education for HCPs involved in the care of individuals with IgA Nephropathy (IGAN) disease across a variety of clinical settings, specifically focusing on:
- Immunopathophysiology of IgAN, exploring the role of the mucosal immune system in IgAN and how it may be leveraged to develop new treatments.
- Treatment options for adult patients with IgAN, and factors to consider, particularly in patients at risk of progressive kidney function loss and treatment targets in order to provide an overview of their mechanism of action, efficacy and safety (e.g, approved treatment options/with supporting data, combination therapy, and emerging treatments, as per KDIGO updated guidelines).
- Share the latest scientific evidence endorsing the clinical trial results regarding nefecon’s potential disease-modifying effects in IgAN.
- Monitoring treatment response to be able to list indications for continuing, modifying and stopping therapy, including the use of validated biomarkers to support early clinical decisions. This also involves evaluating potential adverse effects and considerations for post-treatment management (i.e., after nefecon’s treatment cycle).
Learning objectives
After completing this educational activity, learners should be able to:
- Outline and express an enhanced understanding of , the epidemiology of IgAN.
- Identify how the pathophysiology of IgAN may be leveraged to optimize current treatments (e.g., the role of the mucosal immune system for nefecon) or develop new therapeutic options (e.g., the role of the alternative and lectin pathways for targeted complement inhibitors).
- Recognize different clinical presentations of IgAN and identify relevant diagnostic investigations to establish a diagnosis according to the 2024 KDIGO draft guidelines.
- List and describe validated and emerging biomarkers (e.g., complement protein staining in kidney biopsy) that can play a role in assessing disease progression and treatment response to support the implementation of newer therapies in clinical practice, according to 2024 KDIGO draft guidelines.
- Explain how the targeted-release formulation of budesonide differs from other corticosteroid preparations, including other modified-release formulations.
- Discuss the updated key clinical data, particularly those from the recently published phase 3 NefIgArd trial and 2-year results, along with the main endpoints evaluated in those studies and the latest scientific evidence endorsing the clinical trial results on nefecon’s potential disease-modifying effects in IgAN.
- Identify ongoing updates in the 2024 KDIGO draft guidelines.
- Choose the most appropriate treatment strategy for an individual adult patient by interpreting and applying relevant recommendations and updated guidelines for managing IgAN, considering patient characteristics (including ethnicity), clinical factors, and the safety and efficacy of available agents.
Target Audience
This activity is intended for HCPs involved in the care of people with IGAN such as Nephrologists and Immunologists. In addition the program will be made available to other HCPs such as primary care physicians, internal medicine specialists and advanced practice providers (nurse practitioners and physician assistants)
Enduring Materials CE Activity
Release Date: November 25, 2024
Credit Date termination: February 25, 2026
Continuing Education Information
Oakstone Publishing is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Disclosures
Faculty disclosures
Dr. Dana Rizk has disclosed the following financial relationships:
- Speaker fees: Calliditas Therapeutics (Pharmalink), Chinook Pharmaceuticals, Otsuka Pharmaceuticals, VeraTherapeutics, BioCryst,Argenx, AlpineImmune Science,GSK
- Consultant:Novartis,George Clinical,Eledon Pharmaceuticals, Otsuka Pharmaceuticals (Visterra), Calliditas Therapeutics (Pharmalink), Chinook Pharmaceuticals, LaRoche,Vera Therapeutics, BioCryst
- Grant and Research Funding: Reata Pharmaceuticals, Travere Therapeutics, (Retrophin),Calliditas Therapeutics (Pharmalink),Otsuka Pharmaceuticals (Visterra),Vertex Pharmaceuticals,Chinook Pharmaceuticals,Vera Therapeutics,LaRoche
Dr. Jonathan Barratt has disclosed the following financial relationships:
- Consultant fees and Speaker fees: Alnylam, Argenx, Astellas, BioCryst, Calliditas, Chinook, Dimerix, Galapagos, Novartis, Omeros, Travere Therapeutics, Vera Therapeutics, Visterra
- Clinical Trials: ADU-CL-19 & ALIGN (Chinook), APPLAUSE (Novartis), ARTEMIS-IGAN (Omeros), ENVISION (Visterra), NefIgARD (Calliditas), ORIGIN (Vera Therapeutics)
- Grant Support: Argenx, Calliditas, Chinook, Galapagos, GlaxoSmithKline, Novartis, Omeros, Travere Therapeutics, Visterra
- Research: Argenx, Calliditas, Chinook, Galapagos, GlaxoSmithKline, Novartis, Omeros, Travere Therapeutics, Visterra
Dr. Vladimir Tesar has disclosed the following financial relationships:
- Consultant fees and Speaker fees: Novartis, Stada AG
- Clinical Trials: NefIgARD (Calliditas), ORIGIN (Vera Therapeutics), Phase 2 ENVISION (Otsuka), Sparsentan (Travere Therapeutics)
Oakstone Publishing has assessed conflict of interest with its faculty, authors, editors, and any individuals who were in a position to control the content of this CME activity. Any identified relevant conflicts of interest have been mitigated. Oakstone Publishing’s planners, content reviewers, and editorial staff disclose no relationships with ineligible entities.
Accreditation
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Oakstone Publishing and Skymedcare. Oakstone Publishing is accredited by the ACCME to provide continuing medical education for physicians.
Designation
Oakstone Publishing designates this enduring material for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Commercial Support
Educational Support for this activity was provided by an independent medical educational grant from Calliditas Therapeutics.
Participation Costs
There is no cost to participate in this CE activity.
CME Inquiries
For all CME policy-related inquiries, please contact us at [email protected]
How to Earn CE Credit
Physicians, Physician Assistants, Nurse Practitioners, Nurses and other health professionals
1.Go to the following web site:https://my-ime.com/
2.Register or enter your profile ID.
3.Complete the activity. Your CE records will be electronically sent to and maintained on your Learner dashboard.
Collaboration
Developed with the collaboration of KDIGO
1) Selvaskandan H, Barratt J, Cheung CK. Int J Immunogenet. 2022;49(1):8–21.
2) Tesař V, Radhakrishnan J, Charu V, et al. Kidney Int Rep. 2023;8(9):1730–1740.
3) Yeo SC, Goh SM, Barratt J. Nephrology (Carlton). 2019;24(9):885–895.
4) KDIGO Guidelines. KDIGO 2024 Clinical practice guideline for the management of IgAN – draft for public review. https://kdigo.org/wp-content/uploads/2024/08/KDIGO-2024-IgAN-IgAV-Guideline-Public-Review-Draft.pdf. Updated August 2024. Accessed September 4, 2024.
5) Floege J, Rauen T, Tang SCW. Semin Immunopathol. 2021;43(5):717–728.
