PARASOL-MN INTERIM MEETING

The PARASOL (Proteinuria and Other Biomarkers as Endpoints for Clinical Trials in Kidney Disease) project is a global, multi-stakeholder collaboration created in 2023 to tackle barriers to efficient kidney disease trials—starting with FSGS and then expanding to APOL1-associated kidney disease and membranous nephropathy. Led by academic investigators and kidney health nonprofits working in close collaboration with regulators and patient representatives, PARASOL has built a shared data and analytics platform that brings together longitudinal registry data, detailed phenotyping, and rigorous statistical methods to better understand disease trajectories and potential surrogate endpoints. Through a series of focused workshops and webinars, the consortium has created a common language around disease definitions, harmonized trial endpoints, and developed practical guidance for using real-world data to inform study design.

To date, PARASOL has delivered proof-of-concept that pooled registry and longitudinal data can be used to evaluate candidate surrogate endpoints, clarify inclusion criteria, and de-risk rare kidney disease trials for sponsors and investigators. Building on this foundation, the current phase of PARASOL is focused on expanding disease areas, deepening analytic work on endpoints and subgroups, and strengthening partnerships with regulators and industry to translate findings into actionable trial strategies and future guidance. The overarching goal is to create a sustainable, scalable platform that accelerates the development of effective therapies for rare and complex kidney diseases by aligning stakeholders around shared data, shared methods, and a shared vision for more efficient, patient-centered trials.

The goal of this meeting is to advance the understanding of potential surrogate endpoints for approval of new treatments for primary membranous nephropathy. The interim meeting will be used to discuss the results of the initial PARASOL-MN analyses and engage in a data-driven discussion to steer next steps in the project.