Clinical kidney journal · 2026
Twelve-month real-world outcomes of sparsentan in a multicenter Spanish IgA nephropathy cohort.
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García-Carro Clara, Rodríguez-Moreno Antolina, Cordero Lucía, Pérez-Gómez María Vanessa, Rusiñol Helena Marco, Pasache Enrique, Morales Alejandro, Zamora Rocío, Parra Diego, Villa Juan, Guillén-Olmos Elena, Coll-Brito Verónica, Álvarez Álvaro, Bordignon Juliana, Arcal Carola, Gracia Olga, Delgado Patricia, Soler María José, Sánchez-Fructuoso Ana I
Аннотация
BACKGROUND: Sparsentan has demonstrated significant antiproteinuric effects in randomized trials of IgA nephropathy (IgAN). However, real-world evidence remains scarce and is largely limited to short-term follow-up. Data on the durability of the antiproteinuric response in routine clinical practice are still lacking.
METHODS: This multicenter retrospective study included patients with biopsy-proven IgAN treated with sparsentan in routine clinical practice across Spanish centers. Patients were eligible if they initiated sparsentan outside a clinical trial and had at least 3 months of follow-up. The primary outcome was the proportion of patients achieving a >50% reduction in proteinuria at 3 months (responders). Secondary outcomes included changes in proteinuria and kidney function at 6 and 12 months, as well as safety.
RESULTS: A total of 41 patients were included. The median age was 42 years, with a median baseline estimated glomerular filtration rate (eGFR) of 44 ml/min/1.73 m2 and 95% receiving concomitant sodium-glucose cotransporter-2 (SGLT2) inhibitors. Median baseline proteinuria was 1163 mg/24 h. At 3 months, proteinuria decreased to 772 mg/24 h (median reduction 44.1%), with 51% of patients achieving a >50% reduction. Among patients with extended follow-up, the antiproteinuric effect was sustained at 6 months (median reduction 46.9%) and persisted at 12 months (median reduction 38.9%), despite increased variability. Notably, kidney function remained stable throughout follow-up, despite a moderately reduced baseline eGFR. No clinically relevant hyperkalemia or severe adverse events were observed.
CONCLUSIONS: In this multicenter real-world Spanish cohort, sparsentan was associated with a sustained reduction in proteinuria in patients with biopsy-proven IgAN, maintained up to 12 months, along with preserved kidney function even in those with moderately reduced baseline eGFR, and a favorable safety profile. These findings support the effectiveness of sparsentan on top of contemporary standard of care and provide early evidence of sustained benefit in routine clinical practice.
METHODS: This multicenter retrospective study included patients with biopsy-proven IgAN treated with sparsentan in routine clinical practice across Spanish centers. Patients were eligible if they initiated sparsentan outside a clinical trial and had at least 3 months of follow-up. The primary outcome was the proportion of patients achieving a >50% reduction in proteinuria at 3 months (responders). Secondary outcomes included changes in proteinuria and kidney function at 6 and 12 months, as well as safety.
RESULTS: A total of 41 patients were included. The median age was 42 years, with a median baseline estimated glomerular filtration rate (eGFR) of 44 ml/min/1.73 m2 and 95% receiving concomitant sodium-glucose cotransporter-2 (SGLT2) inhibitors. Median baseline proteinuria was 1163 mg/24 h. At 3 months, proteinuria decreased to 772 mg/24 h (median reduction 44.1%), with 51% of patients achieving a >50% reduction. Among patients with extended follow-up, the antiproteinuric effect was sustained at 6 months (median reduction 46.9%) and persisted at 12 months (median reduction 38.9%), despite increased variability. Notably, kidney function remained stable throughout follow-up, despite a moderately reduced baseline eGFR. No clinically relevant hyperkalemia or severe adverse events were observed.
CONCLUSIONS: In this multicenter real-world Spanish cohort, sparsentan was associated with a sustained reduction in proteinuria in patients with biopsy-proven IgAN, maintained up to 12 months, along with preserved kidney function even in those with moderately reduced baseline eGFR, and a favorable safety profile. These findings support the effectiveness of sparsentan on top of contemporary standard of care and provide early evidence of sustained benefit in routine clinical practice.