Abstract: SA-PO0827
Characteristics of Trial-Eligible Patients with FSGS Within a Real-World Environment: Initial Insights from ACTION3
Session Information
- Glomerular Management: Real-World Lessons and Emerging Therapies
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Munis, Mercedes A., Kaiser Permanente Southern California, Pasadena, California, United States
- Chen, Qiaoling, Kaiser Permanente Southern California, Pasadena, California, United States
- Smith, Alisha J., Dimerix Bioscience, Melbourne, South Australia, Australia
- Luther, Devon, Kaiser Permanente Southern California, Pasadena, California, United States
- Fuller, David E., Dimerix Bioscience, Melbourne, South Australia, Australia
- Sim, John J., Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Background
FSGS is a heterogenous glomerular disease with highly variable clinical course leading to variations in treatment patterns, response rates, and relapses. This presents a challenge to study therapeutic advancements for FSGS which is a rare disease that is associated with poor outcomes. Within a real-world clinical environment in the United States, we sought to determine the proportion of trial eligible patients with FSGS and further characterize this population.
Methods
We conducted a cross-sectional study (2018-2024) within Kaiser Permanente Southern California (KPSC) of patients (age 12-80yrs) with a kidney biopsy demonstrating FSGS as the first diagnosis on pathology report. Biopsies for kidney transplant, nephrectomy, or biopsies with a diagnosis of secondary FSGS were excluded. Using the most recent outpatient laboratory results, we applied inclusion and exclusion criteria to determine trial eligible patients. The primary inclusion criteria were having an eGFR 25-120ml/min and UPCR >1.5g/g.
Results
Among 3,142 patients with biopsy describing FSGS, we identified 933 (29.7%) with primary, undetermined cause, or genetic FSGS. After applying exclusionary criteria reflective of the ACTION3 Trial, 136 (14.6%) were potentially trial eligible. The mean age (SD) was 52.9 years (16.6); 52.9% were male, 41.2% were Hispanic, 22.8% White, 22.1% Asian/Pacific Islander, and 12.5% Black race. The mean Elixhauser comorbidity score (SD) was 4.0 (2.4), median eGFR (IQR) 44.0 (33.2, 66.8) ml/min per 1.73 m2 and median (IQR) UPCR 2.8 (2.1, 3.9) g/g. Severe obesity was present in 9%.
Conclusion
Our “clinical snapshot” demonstrated that trial eligible FSGS patients represent a small proportion of the real world FSGS population. Our findings illustrate the challenges in studying therapeutic advances in FSGS due to variable clinical course where patients are captured at different phases in their clinical courses of disease.
Funding
- Commercial Support – Dimerix Bioscience