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Kerendia is indicated for the treatment of chronic kidney disease (Stages 3 and 4 with albuminuria) associated with type 2 diabetes in adult patients.

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

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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.

cumulative_incidence

Adapted from Bakris

  • callout
    The components of the composite primary outcome were directionally consistent with Kerendia

*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.

Kerendia Efficacy: Secondary composite CV outcome

Key secondary composite CV endpoint consisted of CV death, non-fatal MI, non-fatal stroke, or hospitalisation for heart failure

Kerendia is not licensed for this. Kerendia is indicated for the treatment of chronic kidney disease (Stages 3 and 4 with albuminuria) associated with type 2 diabetes in adult patients.

Secondary Composite CV outcome

Adapted from Bakris

  • callout
    The risk of CV disease and mortality associated with T2D is further exacerbated by the presence of CKD - Analysis of the composite CV outcome was prespecified in FIDELIO-DKD

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

Outcomes were assessed in time-to-event analyses

clinical-efficacy-hierarchical-endpoint-analysis

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])
*

eGFR

Kerendia

Placebo

Mean at baseline ± SD (mL/min/1.73 m²)

44.4 ± 12.5

44.3 ± 12.6

LSM* change in slope from baseline to month 4 highlighted in blue (vertical dotted line) on the graph below, (ml/min/1.73 m²)

-3.18
95% CI:
(-3.44 to -2.91)

-0.73
95% CI:
(-1.03 to -0.44)

LSM* change in slope from Month 4 highlighted in blue (vertical dotted line) on the graph below, to end of study/discontinuation (mL/min/1.73 m²)

-2.66
95% CI:
(-2.96 to -2.36)

-3.97
95% CI:
(-4.27 to -3.66)

Screenshot

Adapted from Bakris

Number of patients at each time point

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.

Learn about adverse events

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARR=absolute risk reduction; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; DKD=diabetic kidney disease; eGFR=estimated glomerular filtration rate; HbA1c=glycated haemoglobin; HR=hazard ratio; LSM=least squares mean; MI=myocardial infarction; MOD=mechanism of disease; MOA=mode of action; NNT=number needed to treat; RRR=relative risk ratio; SBP=systolic blood pressure; SD=standard deviation; SGLT2=sodium-glucose co-transporter 2; T2D=type 2 diabetes; UACR=urinary albumin-to-creatinine ratio.

PP-KER-GB-0803 | March 2025

    • 1
      UK Kerendia SmPC
    • 2
      Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229.
    • 3
      Meraz-Muñoz AY, et al. Kidney360. 2021;2(6):1042-1047.
    • 4
      Agarwal R, et al. J Am Soc Nephrol. 2022;33(1):225-37