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FIDELIO-DKD trial

On top of standard of care compared to placebo*

Firialta significantly slowed CKD progression1

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Primary endpoint
at 36 months

18% RRR

HR=0.82
(95% CI:
0.73-0.93)
P=0.001

3.4% ARR

(95% CI: 0.6-6.2)

NNT: 29

(95% CI: 16-166)

Treatment benefit was consistent amongst the components and key prespecified subgroups1

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You can protect the health of your patients' kidneys for the future
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FIDELIO-DKD trial

On top of standard of care compared to placebo

Secondary composite endpoint consisted of kidney failure, sustained decline in eGFR of ≥57%, and renal death1†

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24% RRR

HR=0.76
(95% CI:
0.65-0.90)

Exploratory analysis was not formally tested due to the hierarchical statistical plan. Firialta is not indicated to reduce the risk of renal death.1

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FIDELIO-DKD trial

In an exploratory data analysis vs placebo

Firialta led to a 31% greater reduction in UACR from baseline by month 41

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Geometric mean UACR (mg/g) at baseline ± geometric SD:
  • Firialta: 798.79±2.65
  • Placebo: 814.73±2.67

On top of
standard of care

At 4 months

31%

HR=0.82
(95% CI:
0.66-0.71)

2022 ADA Standards of Care recommend:

Reducing urinary albumin by ≥30% in patients with CKD who have UACR ≥300 mg/g to slow CKD progression.2

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Lower albuminuria is associated with lower renal and CV risk2
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FIDELIO-DKD trial

Patients on Firialta experienced an initial decrease in eGFR (mean 2 mL/min/1.73 m2) that attenuated over time vs placebo3

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Mean change from month 4 to permanent discontinuation or end of study:
Kerendia: -2.66 (-2.96 to -2.36)
Placebo: -3.97 (-4.27 to -3.66)

Mean change from baseline to month 4:
Kerendia: -3.18 (-3.44 to -2.91)
Placebo: -0.73 (-1.03 to -0.44)

Mean eGFR at baseline ± SD:
Kerendia: 44.4±12.5 mL/min/1.73 m2
Placebo: 44.3±12.6 mL/min/1.73 m2


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Prespecified pooled analysis

Reduction in risk across individual components of renal composite endpoint vs placebo1,4,5

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FIGARO-DKD trial

On top of standard of care compared to placebo

Firialta significantly reduced the risk of CV events4

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Primary endpoint
at 36 months

13% RRR

HR=0.87
(95% CI:
0.76-0.98)
P=0.03

2.1% ARR

(95% CI: 0.4-3.8)

NNT: 47

(95% CI: 26-226)

The effect of Firialta on the primary outcome was consistent across prespecified subgroups4

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You can give your patients the CV protection they need now4
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FIGARO-DKD trial

Reduction in risk of CV events was generally consistent with Firialta4

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Prespecified pooled analysis

Reduction in risk across individual components of CV composite endpoint vs placebo5

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Latest guideline recommendations from ADA, KDIGO, AACE, and the ADA and KDIGO consensus report2,6-8

Use Firialta as part of the comprehensive approach to slowing CKD progression and reducing the risk of CV events in patients with CKD and T2D3

    ADA GUIDELINES2

    Level A recommendations:
    CKD and risk management: “In patients with CKD who are at increased risk for CV events or CKD progression or are unable to use an SGLT-2i, a nonsteroidal MRA (finerenone) is recommended to reduce CKD progression and CV events.”

    CVD and risk management: “For patients with T2D and CKD treated with maximum tolerated doses of ACE inhibitors or ARBs, addition of finerenone should be considered to improve CV outcomes and reduce the risk of CKD progression.”

    KDIGO GUIDELINES6

    Grade 2A recommendation:
    “We suggest a nonsteroidal mineralocorticoid receptor antagonist with proven kidney or cardiovascular benefit for patients with T2D, an eGFR ≥25 mL/min/1.73 m2, normal serum potassium concentration, and albuminuria despite maximum tolerated dose of RAS inhibitor.”

    AACE GUIDELINES7

    Grade 1A recommendation:
    “The nonsteroidal mineralocorticoid antagonist finerenone is also recommended for kidney and heart protection in T2D…because it reduced risk of substantial GFR decline, kidney failure, HF and ASCVD events, and related deaths in a broad T2D population ranging from those with microalbuminuria to advanced CKD.”

    ADA and KDIGO consensus report8
    “A nonsteroidal MRA with proven kidney and CV benefit is recommended for patients with T2D, eGFR ≥25 mL/min/1.73 m2, normal serum potassium concentration, and albuminuria (ACR ≥30 mg/g) despite maximum tolerated dose of RAS inhibitor.”

    Learn about adverse events
    * Approximately 97% of patients in the FIDELIO-DKD trial were on an antidiabetic medication (insulin [65.1%], GLP-1 receptor agonists [6.7%], SGLT2 inhibitors [4.4%]).1
    † Kidney failure was defined as chronic dialysis or kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m2 over ≥4 weeks.1
    ‡ Least-squares mean change from the baseline level in the full analysis set.1
    § Primary composite endpoint for FIDELIO-DKD and secondary composite endpoint for FIGARO-DKD.1,4
    II Defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m2.1,4
    Events were classified as renal death if the patient died, if RRT had not been initiated despite being clinically indicated, and if there was no other likely cause of death.5
    # Treatment with 10 or 20 mg once daily in addition to maximum tolerated labelled doses of an ACEi or ARB.5

     

    AACE=American Association of Clinical Endocrinology; ACE=angiotensin-converting enzyme; ACEi=angiotensin-converting enzyme inhibitor; ACR=albumin-to-creatinine ratio; ADA=American Diabetes Association®; ARB=angiotensin receptor blocker; ASCVD=atherosclerotic cardiovascular disease; BP=blood pressure; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; GFR=glomerular filtration rate; GLP-1=glucagon-like peptide-1; HbA1c=glycated haemoglobin; HF=heart failure; HR=hazard ratio; KDIGO=Kidney Disease: Improving Global Outcomes; MI=myocardial infarction; MR=mineralocorticoid receptor; MRA=mineralocorticoid receptor antagonist; RAS=renin-angiotensin system; RRR=relative risk reduction; RRT=renal replacement therapy; SBP=systolic blood pressure; SGLT2=sodium-glucose cotransporter 2; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.

    References:

    • Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025. Return to content
    • American Diabetes Association® Professional Practice Committee; Draznin B, et al. Diabetes Care. 2022;45(suppl 1):S144-S184. Return to content
    • Firialta® Product Insert approved by NPRA 4th April 2024. Return to content
    • Pitt B, et al. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956. Return to content
    • Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777. Return to content
    • Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. Kidney Int. 2022;102(5S):S1-S127. doi:10.1016/j.kint.2022.06.008. Return to content
    • Blonde L, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. Endocr Pract. 2022;28(10):923-1049. doi:10.1016/j.eprac.2022.08.002. Return to content
    • de Boer IH, et al. Diabetes Management in Chronic Kidney Disease: A Consensus Report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO). Diabetes Care. 2022. https://doi.org/10.2337/dci22-0027. Return to content

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