Abstract: INFO11-SA
IgAN Insights from Treatment Experience (IgNITE): A Multicountry Integrated Framework to Advance Real-World Evidence in IgAN
Session Information
- Informational Posters - 3
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Rizk, Dana V., University of Alabama at Birmingham Health System, Birmingham, Alabama, United States
- Wada, Jun, Okayama Daigaku, Okayama, Okayama Prefecture, Japan
- Tang, Sydney, The University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong, Hong Kong
- Gallego, Daniel, European Kidney Patients Federation, Madrid, Spain
- Hirst, Ceri, Novartis Pharmaceuticals UK Ltd, London, England, United Kingdom
- Desai, Manasi Mital, Novartis Pharmaceuticals UK Ltd, London, England, United Kingdom
- Koukaroudi, Dimitra, Novartis Pharmaceuticals UK Ltd, London, England, United Kingdom
- Huber, Tobias B., Universitatsklinikum Hamburg-Eppendorf, Hamburg, HH, Germany
Description
IgA nephropathy (IgAN) is a progressive, heterogeneous immune-mediated kidney disease with an expanding range of therapeutic options. Robust real-world evidence (RWE) is needed to understand how therapies are used in clinical practice and their impact on patient outcomes. However, IgAN RWE is often constrained by heterogeneous data availability, fragmented data sources, variable diagnostic and clinical documentation practices, with limited sample sizes and longitudinality. The IgAN Insights from Treatment Experience (IgNITE) program aims to address these challenges through a flexible, coordinated research infrastructure, focused on the evolving IgAN treatment landscape.
IgNITE is a global umbrella RWE program designed to evaluate IgAN patients receiving novel therapies, including iptacopan and atrasentan, focusing on baseline characteristics, treatment patterns and long-term outcomes. There are currently 10 countries in scope from Europe, the Americas, the Middle East and Asia Pacific. Country-specific studies use locally appropriate designs and data sources, such as electronic case report form-based cohorts, electronic medical records, and registries. Standardized umbrella documentation has been developed (protocols, statistical analysis plans, data specifications, etc.) to harmonize data collection. The established US IgAN registry APPRISE will be integrated into IgNITE, contributing to a comprehensive, globally representative evidence base. Data are processed according to local governance and integrated as patient-level or aggregated data into the IgNITE Evidence Nexus (IEN), a secure global platform enabling common data model mapping, quality control, pooled analyses and interactive visualization. First data transfer to the IEN is planned for late 2026, to be followed by regular data refreshes and analyses. A steering committee of four independent IgAN clinical experts and one patient representative guides scientific strategy, research priorities and publication planning.
The program accommodates differences in data maturity, treatment availability, local regulations, governance requirements and operational readiness. IgNITE aspires to advance understanding of IgAN, its progression and treatments in the real world, for patients and the wider healthcare community.
Funding
- Novartis Pharma AG