The Humanistic Burden of Focal Segmental Glomerulosclerosis on Patients and Care‑Partners in the United States
Quality of Life Research – 2025
Focal segmental glomerulosclerosis (FSGS) is a progressive kidney condition characterized by podocyte injury, proteinuria, and declining kidney function, often leading to kidney failure.1-4 Slowing disease progression is a primary goal of FSGS treatment, with reductions in proteinuria considered a critical component of disease management.1,5,6
Available estimates indicate that both the incidence and prevalence are increasing globally.1,4 Ascertaining these epidemiological data is essential to quantify the burden of FSGS on healthcare systems, as data are limited.1,7
To estimate the FSGS prevalence in the US and evaluate how baseline chronic kidney disease (CKD) stage and proteinuria levels impact HRU and FSGS cost.1
This was a retrospective cohort study conducted in the US using Optum de-identified Market Clarity Data and proprietary natural language processing (NLP) data.1
Patients were identified by ICD-10 codes and NLP terms during the identification period (January 2001 – March 2021).1* A total of 9,899 patients and 1,082 patients were included in the prevalence cohort and the HRU cohort, respectively.1
FSGS prevalence was estimated by standardizing to the general US population using data from the 2021 US Census Bureau data.1
HRU outcomes included the mean per-patient-per-month (PPPM) number of admissions, visits, or claims and the proportion of patients with ≥11:
HRU outcomes were stratified by baseline CKD stage and proteinuria cutoffs (urinary protein-creatinine ratio [UPCR] thresholds: >1.5 and ≥3.5 g/g).1
In the US, a progressive increase in estimated FSGS prevalence was observed during the study period1
Average annualized standardized prevalence (2016-2020) was 212.6 per million, and prevalence increased every year throughout the study period (158.0 per million in 2016 versus 260.1 per million in 2020).1 Prevalence rates were highest in the Black population.1
Economic burden associated with FSGS increased with greater disease severity and higher levels of proteinuria1
FSGS costs increased with CKD progression.1 Advanced baseline CKD stage was associated with higher PPPM total costs (CKD stage 1: $2,431 vs. CKD stage 5: $14,666 [P<0 .001]).1
Similarly, FSGS costs increased with higher proteinuria levels.1 At both proteinuria thresholds (>1.5 g/g and ≥3.5 g/g), patients with UPCR levels exceeding each threshold incurred greater mean PPPM total costs versus those with UPCR levels below each threshold.1
Overall, the mean total medical FSGS costs, which were primarily driven by outpatient costs, were higher for patients with FSGS vs. those without FSGS ($59,753 vs. $8,431 pre-patient-per-year [PPPY]; P<0.001).1
Higher CKD stage and higher levels of proteinuria were associated with higher HRU1
As disease severity increased, the proportion of patients with inpatient admissions and ED visits rose significantly, alongside higher PPPM rates of inpatient, ED, and outpatient visits, indicating greater utilization in advanced CKD stages1:
Compared with proteinuria levels below the thresholds, levels >1.5 g/g or ≥3.5 g/g were associated with higher proportions of patients with ≥1 inpatient visit or pharmacy claim.1 A trend toward a higher proportion of patients with ED visits was observed for levels exceeding 3.5 g/g compared with levels below the threshold.1
FSGS prevalence is rising, with substantial clinical and economic burden.1 Higher proteinuria and advanced CKD are associated with increased FSGS costs. 1 Early intervention strategies that reduce proteinuria and slow disease progression may reduce the burden.1
*The study and identification period for the prevalence cohort were from January 1, 2007, through March 31, 2021. Patients in the HRU/cost cohort were identified from July 1, 2007, through September 30, 2020, to allow for a 6-month baseline and follow-up period.1
The study and supplement were funded by Travere Therapeutics, Inc. Please see the publication for the full list of disclosures.
CKD, chronic kidney disease; ED, emergency department; FSGS, focal segmental glomerulosclerosis; HRU, healthcare resource utilization; ICD-10, International Statistical Classification of Diseases and Related Health Problems 10th Revision; NLP, natural language processing; PPPM, per-patient-per-month; SDS, signs, disease and symptoms; UPCR, urinary protein-creatinine ratio.
MA-DS-26-0026 | April 2026