Differentiating Primary and Secondary FSGS Using Non‑Invasive Urine Biomarkers
Clinical Kidney Journal – 2023
Focal segmental glomerulosclerosis (FSGS) is a common histological pattern of kidney injury that contributes to proteinuria and progression to kidney failure.1,2
There are multiple histological types of FSGS that correlate with variable clinical outcomes.1,3,4
Real-world evidence on the distribution and severity of FSGS histology at diagnosis across diverse populations remains limited.1
This study aimed to characterize FSGS histology patterns, their severity, and clinical correlates among United States (US) adults at the time of kidney biopsy.1
A retrospective analysis of kidney biopsies from adults diagnosed with FSGS between 2016 and 2020 was conducted using data from Arkana Laboratories.1
Histological variables included1:
Demographics at kidney biopsy
Among 2,011 patients with FSGS, most were male (56.4%), and the overall mean age at biopsy was 49.1 ± 17.2 years.1 Compared with White patients (40.6%, 817/2,011), Black patients (23.6%, 474/2,011) were younger (52.8 vs. 45.5 years) and had lower eGFR (53.5 vs. 43.1 mL/min/1.73 m²).1
Severe histological features were common at diagnosis1
Global GS ≥50% and IFTA ≥50% were each observed in 1 in 5 kidney biopsies, while diffuse foot process effacement (≥80%) was seen in 47.3%.1
Severe FSGS histology was associated with Black race, advanced chronic kidney disease (CKD) stage, and nephrotic proteinuria1
Severe histological disease was more likely in Black vs. White patients (odds ratio [OR]: 2.46; 95% confidence interval [CI]: 1.59-3.79; P<0.001). The odds of severe histological disease were also associated with more advanced CKD (OR for stage 5 vs. stage 1-2: 22.59; 95% CI: 9.36-54.49; P<0.001).1
Diffuse foot process effacement was more common in those with nephrotic vs. non-nephrotic proteinuria (60.1% vs. 23.7%; P<0.001).1
NOS lesions were the most common type in both groups but were more frequent in nephrotic patients (80.3% vs. 64.0%; P<0.001).1
At the time of biopsy, Black patients were more likely to be younger and present with advanced CKD and more severe histological disease compared with White patients.1
Timelier identification of FSGS could increase the opportunity for therapeutic intervention, especially for high-risk patients.1
This study was funded by Travere Therapeutics, Inc. Please see the publication for the full list of disclosures.
CKD, chronic kidney disease; CI, confidence interval; eGFR, estimated glomerular filtration rate; FSGS, focal segmental glomerulosclerosis; GS, glomerulosclerosis; IFTA, interstitial fibrosis and tubular atrophy; NOS, not otherwise specified; OR, odds ratio.
MA-DS-25-0059 | July 2025