Kidney Week

Abstract: FR-PO0669

A Registry-Based Study of Treatment Patterns and Outcomes in Patients with FSGS in the United States

Session Information

• Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - ANCA/FSGS
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Khan, Anam M., RTI Health Solutions, Durham, North Carolina, United States

Anam M. Khan, PhD

• Lewing, Benjamin, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States

Benjamin Lewing, PhD

• Helmuth, Margaret, University of Michigan, Ann Arbor, Michigan, United States

Margaret Helmuth, MA

• Layton, J. Bradley, RTI Health Solutions, Durham, North Carolina, United States

J. Bradley Layton, PhD

• Gidey, Saba, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States

Saba Gidey, PharmD

• Demas, Caroline, University of Michigan, Ann Arbor, Michigan, United States

Caroline Demas, MPH

• Dellepiane, Sergio, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States

Sergio Dellepiane, MD, PhD

• Mariani, Laura H., University of Michigan, Ann Arbor, Michigan, United States

Laura H. Mariani, MD, MS, FASN

Background

Focal segmental glomerulosclerosis (FSGS) is a podocytopathy associated with nephrotic syndrome (NS) and risk of kidney failure. Patients with FSGS have substantial unmet medical needs. This study describes the real-world clinical characteristics, treatment patterns, and outcomes among adults with FSGS.

Methods

Data from the CureGN Glomerular Disease Registry was used to identify participants aged ≥18 years with biopsy-confirmed FSGS from 2014 to 2025; the biopsy date was the index date. Participants with NS and without secondary or genetic FSGS or long-term steroid use were included. Follow-up began the day after biopsy and continued until disenrollment, end of data, or death. We assessed treatment response among those who initiated corticosteroids within 1 year of biopsy and had a recorded urine protein-creatinine ratio (UPCR) value at baseline and ≥1 within 8 months of initiation. Participants were responders if they had a complete response (CR; UPCR <0.3 g/g) or partial response (PR; UPCR 0.3–3.5 g/g and <50% of baseline). Among responders, subsequent UPCR values were used to assess relapse. Response and relapse rates were calculated; median and interquartile range (IQR) time to response and relapse were also reported.

Results

A total of 74 participants with FSGS (mean age, 47.2 years; male, 64.9%; mean estimated glomerular filtration rate at biopsy, 60.4 mL/min/1.73m²) were included. Mean time from biopsy to treatment initiation was 35 days. Corticosteroids were the initial treatment for 95.2% of FSGS participants; however, within 12 months, 69% of participants also started another immunosuppressant. Among corticosteroid initiators with UPCR data, 64.5% were responders (15% were CRs). Median (IQR) time to response was 98 days (44.5-182.0). Responders had lower baseline UPCR values and earlier treatment initiation than nonresponders. However, 70% of responders relapsed within 1 year; 75% relapsed within 2 years. Median (IQR) time to 2-year relapse was 89.0 days (68.0-154.0). Median (IQR) time to relapse was longer for CRs (135.5 days [56.0-215.0]) than PRs (89.0 days [71.0-121.0]).

Conclusion

Although most participants with FSGS initially responded to corticosteroids, relapse was common and rapid. Findings highlight the need to initiate therapy early and for more effective therapies that induce durable remission and improve long-term disease control.

Funding

• Commercial Support – Otsuka Pharmaceutical Development and Commercialization, Inc.