The PARASOL Project: Pioneering the Use of Proteinuria as an Endpoint for FSGS
A groundbreaking initiative that accelerated research, collaboration, and innovation in rare kidney diseases.
stay informedWhat is PARASOL?
The PARASOL (Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis [FSGS]) Project is a pioneering initiative co-sponsored by NephCure, the International Society of Glomerular Disease, the U.S. Food and Drug Administration, the Kidney Health Initiative, and the National Kidney Foundation. The primary goal of the project, that started in December 2023, was to validate the use of proteinuria and eGFR-based surrogate endpoints for the accelerated and traditional approval of new treatments for FSGS, facilitating the development of urgently needed therapies.
The collaborative project brought together leading researchers, nephrologists, biostatisticians, industry leaders, patient advocates, and regulatory authorities to drive scientific progress for rare kidney disease treatments.
At its core, PARASOL aimed to:
- Support critical studies through a targeted grant program
- Facilitate collaboration via scientific workshops and industry partnerships
- Drive innovation toward better diagnostics and treatment options
Why it Mattered?
Using proteinuria as a reliable clinical trial endpoint was key to improving treatments and outcomes for FSGS patients. PARASOL accelerated this effort by uniting the scientific, clinical, and regulatory communities around a shared goal — with a notably aggressive project timeline that moved the field forward faster than traditional research efforts.
“PARASOL is an incredible demonstration by the international nephrology community that through generosity and multidisciplinary collaboration, we can answer fundamental, practical scientific questions needed to inform clinical trial design in rare disease,” said Dr. Laura Mariani, PARASOL Co-Chair and Associate Professor of Medicine (Nephrology) at the University of Michigan.
Building Global Consensus Through Scientific Workshops
A cornerstone of the PARASOL Project was its three international scientific workshops, designed to unite top nephrology experts, regulatory authorities, patient advocates, and industry partners around the world using proteinuria and eGFR as clinical trial endpoints for FSGS.

Washington, D.C., Inaugural Meeting
The first PARASOL meeting took place in Washington, D.C., on December 9-10, 2023. Researchers, clinicians, regulators, and patients gathered to discuss developing biostatistical models to better design clinical trials and predict outcomes like kidney failure. They focused on accounting for variability in proteinuria and eGFR and emphasized the need to merge global datasets. The meeting set the foundation for creating practical tools that would improve FSGS clinical trials and drug development strategies. Click here for full details.
Reykjavik, Iceland Workshop
The first major scientific convening of the PARASOL Project took place on June 8–9, 2024, in Reykjavik, Iceland, and marked a significant milestone in the fight against FSGS.
This second overall meeting of PARASOL stakeholders (following the project launch in December 2023) focused on advancing efforts to identify alternative, data-driven endpoints for FSGS clinical trials — beyond the complete remission markers traditionally recognized by the FDA.
Patient-level data assembled from more than 20 international cohorts and registries representing over 3,000 patients were central to the meeting.
Early analyses from datasets such as NEPTUNE, CureGN, the Kidney Research Network, and the UNC Glomerular Disease Collaborative Research Network (GDCRN) were presented.
Breakout sessions and robust discussions examined whether lesser degrees of proteinuria reduction could support accelerated or traditional treatment approvals. The gathering emphasized the urgent need to develop appropriate, feasible indicators of disease progression to help bring new therapies to patients faster.
“We are truly inspired by the community’s response to PARASOL, especially the eagerness of nephrologists and their teams to share their data,” said Dr. Matthias Kretzler, PARASOL Project Co-Chair.
“It was incredibly gratifying to have such a diverse group of stakeholders all in one room, fostering robust and vital discussions,” added Josh Tarnoff, CEO of NephCure.
The Reykjavik meeting paved the way for focused next steps, additional data integration, and more comprehensive discussions at the following workshop.

Bethesda, Maryland Workshop
On October 7–8, 2024, PARASOL hosted a scientific workshop in Bethesda, Maryland, bringing the project’s work to a critical point.
At this workshop, detailed biostatistical analyses of 1,626 FSGS patients were presented, drawing from the global datasets assembled earlier in the year.
Dr. Abigail Smith reported that reductions in proteinuria over 24 months were strongly associated with a reduced risk of kidney failure, findings that were consistent across different patient subgroups and validated in a large independent European cohort. The discussion highlighted the biological plausibility of proteinuria as a surrogate marker, its broad utility in clinical trial design, and the potential to accelerate drug development for FSGS.
“Through generosity and multidisciplinary collaboration, we can answer fundamental scientific questions needed to inform rare disease trial design,” said Dr. Laura Mariani, PARASOL Co-Chair.
PARASOL Conclusions
The Maryland meeting successfully finalized key findings that were shared at the American Society of Nephrology Kidney Week 2024 and prepared for publication in a peer-reviewed journal.
This progress has already started to impact the field. Travere Therapeutics announced the FDA has accepted their supplemental New Drug Application (sNDA) to expand the use of FILSPARI to treat people with FSGS. The FDA plans to review the application and issue a decision by January 13, 2026. If approved, FILSPARI will become the first FDA-approved treatment specifically for FSGS. This milestone further highlights the importance of the PARASOL Project’s contributions toward advancing regulatory pathways and treatment options for patients with rare kidney diseases. Click here to learn more.
On April 28th, 2025, in Melbourne Australia, Dimerix Limited – a biopharmaceutical company with a Phase 3 clinical trial asset, DMX-200, in a rare kidney disease, was able to announce a positive advancement due to the progress created by the PARASOL Project. Dimerix met with the US FDA where it was confirmed that proteinuria-based endpoints could be the basis for full marketing approval of DMX-200 in the US. Click here to learn more.
A New Era of Collaboration
Together, these three workshops exemplified the power of international collaboration in rare disease research. They established the scientific consensus needed to support the regulatory acceptance of proteinuria and eGFR as endpoints — opening the door to faster development and approval of treatments for FSGS. Moving forward, the “PARASOL formula” of rapid, collaborative, multi-stakeholder engagement will serve as a model to accelerate research and treatment development for other rare kidney diseases in urgent need of new therapies.
The PARASOL Grant Program: Supporting Breakthrough Research
The PARASOL Grant Program was a key component of the project, providing critical funding to researchers studying proteinuria in FSGS. The grants supported work on:
Mechanisms of proteinuria in FSGS
Therapeutic targets and potential treatments
Biomarkers and diagnostic advancements
Note: The PARASOL Grant Program is now closed. However, the knowledge gained from these studies continues to inform the field and inspire new research strategies.
Lasting Impact & Future Vision
Through groundbreaking research, critical funding, and an unprecedented spirit of collaboration, the PARASOL Project fundamentally reshaped the landscape of clinical trials for FSGS.
By uniting researchers, clinicians, industry leaders, regulators, and patient advocates, the initiative achieved a major milestone: building strong scientific consensus around the use of proteinuria and eGFR as feasible and meaningful surrogate endpoints for clinical trials.
This accomplishment carries far-reaching implications. For FSGS, it means a clearer, faster pathway for evaluating and approving new therapies — offering renewed hope to patients who urgently need better treatment options. For the broader rare kidney disease community, PARASOL demonstrated that even the most complex research questions can be tackled through rapid, inclusive, data-driven collaboration.
The project’s success is more than a singular achievement; it establishes a proven blueprint for the future. The “PARASOL formula” — bringing together global stakeholders, leveraging existing data, and prioritizing practical solutions — will now serve as a guiding model to accelerate innovation in other rare kidney diseases. Future efforts will build upon the momentum and methodologies pioneered by PARASOL, ensuring that the rare disease community continues to move closer to more effective treatments and, ultimately, cures.