How effective is sparsentan in treating urinary protein

Sparsentane is more effective in treating urinary protein and has the effect of protecting glomerular podocytes and reducing proteinuria. The interim results of the Phase 3 clinical trial showed that sparsentan can reduce urinary protein by 49.8%, which is more than three times that of the control drug irbesartan (15.1%). Sparsentane can block the angiotensin pathway and also block endothelin, resulting in better renal protection. Sparsentan is the first IgA nephropathy therapy that does not suppress the immune system and is highly effective without causing systemic effects.

PROTECT is an international, randomized, double-blind, active-controlled study conducted at 134 clinical practice sites in 18 countries. This study compared sparsentan with irbesartan in adults (age ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1.0 g/day or greater, despite maximizing treatment with a renin-angiotensin system inhibitor for at least 12 weeks.

Study Results: 404 participants were randomly assigned to take either sparsentan (n=202) or irbesartan (n=202). At week 36, the geometric least squares mean percent change in urinary protein-to-creatinine ratio from baseline was statistically significantly greater in the sparsentan group (-49.8%) than in the irbesartan group (-15.1%), resulting in a relative reduction of 41% between groups (least squares mean ratio=0.59).

Conclusions: In adults with IgA nephropathy, once-daily treatment with sparsentan significantly reduced proteinuria compared with irbesartan. The safety profile of Sisentan is similar to that of Irbesartan.

Common side effects of sparsentane include peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia, anemia, acute kidney injury, elevated transaminase, etc. Generally, the symptoms of side effects will vary depending on the patient's condition, physique, and living habits. Of note, to reduce the risk of potentially severe hepatotoxicity, serum aminotransferase levels and total bilirubin should be measured before initiating treatment and monthly for the first 12 months of treatment, and then every 3 months during treatment.

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References

Heerspink HJL, Radhakrishnan J, Alpers CE, Barratt J, Bieler S, Diva U, Inrig J, Komers R, Mercer A, Noronha IL, Rheault MN, Rote W, Rovin B, Trachtman H, Trimarchi H, Wong MG, Perkovic V; PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomized, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1. PMID: 37015244.