Sparsentan Monitoring IgAN — ESENeph MCQ

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ModerateGlomerulonephritisSparsentan Monitoring IgANESENeph

A 38-year-old man with biopsy-confirmed IgA nephropathy has proteinuria of 2.2 g/day despite 6 months of maximal RASi, SGLT2i, and BP optimisation. eGFR is 55 mL/min/1.73m2. He is offered Sparsentan. What is the key monitoring concern with this drug?

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Correct answer: C — Hepatotoxicity – liver function tests must be monitored

Sparsentan carries a risk of hepatotoxicity through its endothelin receptor antagonism (class effect of endothelin receptor antagonists, also seen with Bosentan). The PROTECT trial required regular liver function monitoring. Sparsentan is available via a restricted prescribing programme (REMS in the US) with mandatory LFT monitoring monthly for the first 12 months, then periodically. It is also teratogenic and requires pregnancy prevention measures. Fluid retention from endothelin blockade is another concern.

Reference: PROTECT Trial – Lancet 2023; Sparsentan SPC/FDA Label