WEDNESDAY, Nov. 8, 2023 (HealthDay News) -- No significant differences are seen in the estimated glomerular filtration rate (eGFR) with sparsentan versus irbesartan among patients with focal segmental glomerulosclerosis (FSGS), according to a study published online Nov. 3 in the New England Journal of Medicine to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 2 to 5 in Philadelphia.
Michelle N. Rheault, M.D., from the University of Minnesota Medical School in Minneapolis, and colleagues conducted a phase 3 trial involving patients with FSGS aged 8 to 75 years who were randomly assigned to receive sparsentan or irbesartan (active control) for 108 weeks (182 and 187 patients, respectively).
The researchers found that at 36 weeks, 42.0 and 26.0 percent of patients in the sparsentan and irbesartan groups had partial remission of proteinuria, a response that was sustained through 108 weeks. No significant between-group differences were seen in the eGFR slope at the time of the final analysis at week 108; the difference in total slope (days 1 to 108) between the groups was 0.3 mL/min/1.73 m2 of body-surface area per year; the difference in the slope between the groups from week 6 to 108 was 0.9 mL/min/1.73 m2. From baseline to week 112, the mean change in eGFR was −10.4 and −12.1 mL/min/1.73 m2 with sparsentan and irbesartan, respectively. Similar safety profiles were seen for sparsentan and irbesartan.
"No significant difference in eGFR slope was observed between the sparsentan group and the irbesartan group at 108 weeks, despite a relative reduction in proteinuria with sparsentan," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Travere Therapeutics, which manufactures sparsentan and funded the study.
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