Kerendia®▼ (finerenone) Efficacy | FIDELIO-DKD:

Kerendia significantly slowed CKD progression* vs placebo

^†

FIDELIO-DKD was a double-blind placebo controlled, randomisation trial of 5674 adult patients with CKD and T2D.

Primary composite renal endpoint consisted of kidney failure^‡, a sustained decline of ≥40% in eGFR from baseline over ≥4 weeks, or death from renal causes^§.

§Events were classified as renal death if: (1) the patient died; (2) kidney replacement therapy had not been initiated despite being clinically indicated; & (3) there was no other likely cause of death.

Adapted from Bakris

^*Primary composite outcome of kidney failure, a sustained decrease of ≥40% in eGFR, or death from renal causes. ^†In addition to maximum tolerated dose of ACEi or ARB . ^‡Kidney failure was defined as end-stage kidney disease (initiation of dialysis for ≥90 days or kidney transplantation) or an eGFR <15 mL/min/1.73 m² over ≥4 weeks.

Adapted from Bakris

Kerendia Efficacy: Hierarchical prespecified efficacy outcomes, including the components of the composite outcomes

Outcomes were assessed in time-to-event analyses

Adapted from Bakris

There was no significant between-group difference in the risk of death from any cause; analyses of subsequent prespecified outcomes are, therefore, exploratory.

^*Secondary composite outcome of kidney failure†, a sustained decreased of ≥57% in eGFR (equivalent to a doubling of the serum creatinine level), or death from renal causes.^†Defined as end-stage kidney disease (initiation of dialysis for ≥90 days or kidney transplantation), or an eGFR <15 mL/min/1.73 m2 over ≥4 weeks.

Kerendia Efficacy: Patients on Kerendia experienced an initial decrease in eGFR that attenuated over time vs placebo

Mean change from baseline in eGFR (ml/min/1.73m² [95% CI])^*

Adapted from Bakris

Number of patients at each time point

^*LSM change from the baseline level in the full analysis set.

An acute drop in eGFR with a reduced chronic slope has also been observed with SGLT2 inhibition, as well as renin-angiotensin system inhibitors.

– the decrease in eGFR induced by Kerendia is considered haemodynamic (provoked by natriuresis or a modest blood pressure reduction), as opposed to having a tubular cause.