Phase 3 (Top-line Data)
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Catalyst Info & Data Links
TITLE: Sparsentan in the Treatment of Patients With IgA Nephropathy
ClinicalTrial.gov (NCT03762850): A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)
WHAT IS THE CATALYST EVENT?
Phase 3 Top-line Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
MECHANISM OF ACTION
Sparsentan is an investigational product candidate in Phase 3 clinical development that has a dual mechanism of action combining endothelin receptor type A blockade with angiotensin receptor blockade. Retrophin is developing sparsentan for the treatment of IgAN, as well as for focal segmental glomerulosclerosis (FSGS), rare kidney disorders that often lead to ESRD. In several forms of chronic kidney disease, such as IgAN and FSGS, endothelin receptor blockade has been shown to have an additive beneficial effect on proteinuria in combination with renin-angiotensin blockade via angiotensin receptor blockade or angiotensin converting enzyme inhibitors. Sparsentan has been granted orphan drug designation for the treatment of FSGS by the FDA and European Commission.
IgAN frequently occurs in adolescence or early adulthood, usually in the second and third decades of life.
Estimated incidence of IgAN is 2.5 per 100,000 individuals per year among adults, with geographic, racial and ethnic variations in prevalence.
Prevalence of IgAN may be higher in individuals of Pacific Asian and southern European descent versus those of North American and northern European descent.
In the US, IgAN is the most common primary glomerular disease in young Caucasian adults.
Updated by HC
TVTX, IgA nephropathy (IgAN), Berger's disease, kidney disease immunoglobulin A (IgA), inflammation, Sparsentan
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