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The following is a summary of “Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis,” published in the December 2023 issue of Nephrology by Rheault et al.
Researchers conducted a retrospective study to assess the long-term effectiveness and safety of sparsentan, a promising focal segmental glomerulosclerosis (FSGS) drug, addressing a critical gap in treatment options.
They enrolled patients aged 8 to 75 with FSGS (without known secondary causes, phase 3 trial). The patients were randomly assigned to take either sparsentan or irbesartan (active control for 108 weeks). At the prespecified interim analysis (36 weeks), FSGS partial remission of proteinuria endpoint was accessed (defined as a urinary protein-to-creatinine ratio of ≤1.5 [with protein and creatinine both measured in grams] and a >40% reduction in the ratio from baseline) as the surrogate efficacy endpoint. The main effectiveness measure was the eGFR slope at the final analysis. Additionally, the change in eGFR from baseline to week 112 after treatment and safety assessment were secondary endpoints.
The results showed 371 patients randomized, 184 on sparsentan, and 187 on irbesartan. Sparsentan yielded 42.0% proteinuria remission at 36 weeks (vs. 26.0% with irbesartan, P=0.009), sustained through 108 weeks. No significant eGFR slope differences were found at week 108. Mean eGFR change at week 112 was −10.4 ml/min/1.73 m2 with sparsentan and −12.1 ml/min/1.73 m2 with irbesartan (difference, 1.8 ml/min/1.73 m2; 95% CI, −1.4 to 4.9). Safety profiles between sparsentan and irbesartan were comparable, with similar adverse event frequencies.
They concluded that despite significant proteinuria reduction with sparsentan after 108 weeks in FSGS, kidney function decline remained similar to irbesartan.
Source: nejm.org/doi/full/10.1056/NEJMoa2308550?logout=true
