Sepsis-associated acute kidney injury (SA-AKI) in patients admitted to an intensive care unit is associated with significant morbidity and mortality. There is currently no pharmaceutical treatment.

Although we found no evidence that ilofotase alfa improved survival, it may reduce major adverse kidney events (mortality, new onset, renal replacement therapy >25% reduction in estimated glomerular filtration rate, or rehospitalization) up to 90 days.

Six hundred fifty patients were treated and analyzed for safety; and 649 for efficacy data (ilofotase alfa n = 330; placebo n = 319).

The observed mortality rates in the ilofotase alfa and placebo groups were 27.9% and 27.9% at 28 days, and 33.9% and 34.8% at 90 days.

The trial was stopped for futility on the primary endpoint.

The observed proportion of patients with MAKE90A and MAKE90B were 56.7% and 37.4% in the ilofotase alfa group vs. 64.6% and 42.8% in the placebo group.

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