Abstract: INFO20-FR
Proteinuria and Other Biomarkers as End Points for Clinical Trials in Kidney Disease (PARASOL)
Session Information
- Informational Posters - 2
October 23, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Smith, Abigail R., Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
- Helmuth, Margaret, University of Michigan, Ann Arbor, Michigan, United States
- Beck, Laurence H., Boston Medical Center, Boston, Massachusetts, United States
- Damashek, Laurel J., International Society of Glomerular Disease, Florence, Massachusetts, United States
- Desmond, Hailey, University of Michigan, Ann Arbor, Michigan, United States
- Gibson, Keisha L., The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Gillespie, Barbara S., International Society of Glomerular Disease, Florence, Massachusetts, United States
- Huber, Tobias B., Universitatsklinikum Hamburg-Eppendorf, Hamburg, HH, Germany
- Kretzler, Matthias, University of Michigan, Ann Arbor, Michigan, United States
- Mercer, Alex, JAMCO Pharma Consulting, Stockholm, Sweden
- Nachman, Patrick H., University of Minnesota Twin Cities, Minneapolis, Minnesota, United States
- Parekh, Rulan S., Women's College Hospital, Toronto, Ontario, Canada
- Rahimi, Ashley E., University of Michigan, Ann Arbor, Michigan, United States
- Rovin, Brad, The Ohio State University, Columbus, Ohio, United States
- Tarnoff, Joshua M., Nephcure Kidney International, King of Prussia, Pennsylvania, United States
- Trachtman, Howard, University of Michigan, Ann Arbor, Michigan, United States
- West, Melissa, American Society of Nephrology, Washington, District of Columbia, United States
- Willis, Kerry, National Kidney Foundation Inc, New York, New York, United States
- Zee, Jarcy, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Mariani, Laura H., University of Michigan, Ann Arbor, Michigan, United States
Group or Team Name
- the PARASOL consortium
Description
Rare kidney diseases represent substantial burden, yet progress in therapeutic development is limited. Randomized clinical trials (RCTs) are critical to evaluate novel therapies, and defining feasible, meaningful endpoints is essential for trial success. Changes in proteinuria, estimated glomerular filtration rate (eGFR), and select biomarkers are commonly used to assess efficacy; however, for most conditions, evidence is insufficient to establish a quantitative relationship between changes in laboratory parameters or biomarker levels and clinically relevant outcomes. This gap has hindered drug development and delayed identification and approval of new therapies. PARASOL aims to assemble patient-level data from international observational studies, registries, and completed trials to evaluate relationships between proteinuria and other biomarkers with clinically relevant outcomes, and to develop quantitative models that address treatment related effects to guide RCT design and endpoint evaluation across glomerular diseases.
Initial efforts focused on focal segmental glomerulosclerosis (FSGS), defining relationships between proteinuria and eGFR and long-term outcomes, and identifying surrogate endpoints to support feasible trial design and regulatory pathways. After harmonizing global datasets, a 2024 public workshop sponsored by NephCure, the International Society of Glomerular Disease, the Kidney Health Initiative, the National Kidney Foundation, and the US Food and Drug Administration reported results of analyses based on 1626 patients from 9 data sources. The results demonstrated strong, consistent associations between reduction in proteinuria at 24 months and hazard of kidney failure. The findings were replicated independently in the UK RaDaR registry. The FSGS dataset has grown and remains accessible for stakeholder-driven ancillary analyses.
In 2025 PARASOL expanded to include APOL1 kidney disease and primary membranous nephropathy (pMN). These initiatives leverage global registry, observational, and trial data to robustly evaluate candidate biomarkers as surrogate endpoints for traditional and accelerated approval. APOL1 efforts focus on linking proteinuria with intermediate and long-term disease progression, while pMN studies will also assess serum albumin, PLA2R antibodies, and related measures as potential surrogate endpoints for feasible clinical trials.
Funding
- NephCure, International Society for Glomerular Diseases