FIDELIO-DKD trial

 

On top of standard of care compared to placebo*

Kerendia significantly slowed CKD progression

clinical-efficacy
Primary endpoint at 36 months

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 subgroups

Callout gold icon

You can protect the health of your patients' kidneys for the future

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 death
†

clinical-efficacy2
Exploratory analysis

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

FIDELIO-DKD trial

 

In an exploratory data analysis vs placebo

Kerendia led to a 31% greater reduction in UACR from baseline by month 4

clinical-efficacy3

Geometric mean UACR (mg/g) at baseline ± geometric SD:

  • Kerendia: 798.79±2.65
  • Placebo: 814.73±2.67
At 4 months 31%

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.

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Lower albuminuria is associated with lower renal and CV risk

FIDELIO-DKD trial

 

Patients on Kerendia experienced an initial decrease in eGFR (mean 2 mL/min/1.73 m
2
) that attenuated over time vs placebo

clinical-efficacy4

Prespecified pooled analysis

 

Reduction in risk across individual components of renal composite endpoint vs placebo

clinical-efficacy5

FIGARO-DKD trial

 

On top of standard of care compared to placebo

Kerendia significantly reduced the risk of CV events

clinical-efficacy6
Primary endpoint at 36 months

2.1% ARR

(95% CI: 0.4-3.8)

NNT: 47

(95% CI: 26-226)

The effect of Kerendia on the primary outcome was consistent across prespecified subgroups

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You can give your patients the CV protection they need now

FIGARO-DKD trial

 

Reduction in risk of CV events was generally consistent with Kerendia

clinical-efficacy7

Prespecified pooled analysis

 

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

clinical-efficacy8

Latest guideline recommendations from ADA, KDIGO, AACE, and the ADA and KDIGO consensus report

Use Kerendia as part of the comprehensive approach to slowing CKD progression and reducing the risk of CV events in patients with CKD and T2D

    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.”

    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.”

    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 report

“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
    Abbreviationsexpand_less

    *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%]).

    †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.

    ‡Least-squares mean change from the baseline level in the full analysis set.

    §Primary composite endpoint for FIDELIO-DKD and secondary composite endpoint for FIGARO-DKD.

    IIDefined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m2.

    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.

    #Treatment with 10 or 20 mg once daily in addition to maximum tolerated labelled doses of an ACEi or ARB.

    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.

    Referencesexpand_less
    • 1
      Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025.
    • 2
      American Diabetes Association® Professional Practice Committee; Draznin B, et al. Diabetes Care. 2022;45(suppl 1):S144-S184.
    • 3
      Kerendia Prescribing Information, India 2023.
    • 4
      Pitt B, et al. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956.
    • 5
      Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777.
    • 6
      Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. Kidney Int. 2022;102(5S):S1-S127. doi:10.1016/j.kint.2022.06.008.
    • 7
      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.
    • 8
      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.