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In adult patients with CKD associated with T2D

In the FIDELIO-DKD trial, KERENDIA was proven to significantly slow CKD progression1,2

Primary composite endpoint consisted of kidney failure,* a sustained decline of ≥40% in eGFR, or renal death. The treatment effect reflected a reduction in a sustained decline in eGFR of ≥40% and progression to kidney failure. There were few renal deaths during the trial1

KERENDIA reduced risk of CKD progression by 18% vs placebo

The treatment effect was generally consistent across subgroups, including eGFR at baseline, UACR at baseline, SBP at baseline, and HbA1c at baseline.1,2

*Kidney failure was defined as chronic dialysis or kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m2.1

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; HbA1c=glycated hemoglobin; HR=hazard ratio; RRR=relative risk reduction; SBP=systolic blood pressure; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

KERENDIA significantly reduced risk of CV events1

Key secondary composite endpoint consisted of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure. The treatment effect reflected a reduction in CV death, non-fatal MI, and hospitalization for heart failure1

KERENDIA reduced risk of the CV composite endpoint by 14% vs placebo

The treatment effect was generally consistent across subgroups, including eGFR at baseline, UACR at baseline, SBP at baseline, HbA1c at baseline, and CVD history.1-3

CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; HbA1c=glycated hemoglobin; HR=hazard ratio; MI=myocardial infarction; RRR=relative risk reduction; SBP=systolic blood pressure; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

As published in the New England Journal of Medicine

The FIDELIO-DKD trial evaluated the effect of KERENDIA on renal and CV outcomes in adults with CKD associated with T2D1,2

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5674 adults with CKD associated with T2D randomized 1:1 to receive KERENDIA or placebo

  • Double-blind, placebo-controlled, multicenter, phase 3 study with a median follow-up duration of 2.6 years
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4- to 16-week run-in period to adjust ACEi or ARB to the maximum tolerated labeled dose

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Primary composite endpoint consisted of:

  • Kidney failure*
  • Sustained decline of ≥40% in eGFR
  • Renal death
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Key secondary composite endpoint consisted of:

  • CV death
  • Non-fatal MI
  • Non-fatal stroke
  • Heart failure hospitalization

*Kidney failure was defined as chronic dialysis or kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m2.1

    Select inclusion and exclusion criteria1

    Inclusion and exclusion criteria
    Inclusion and exclusion criteria

    Inclusion

    Treated with standard-of-care background therapy, including maximum tolerated labeled dose of either an ACEi or an ARB

    Serum potassium ≤4.8 mEq/L at screening

    Inclusion and exclusion criteria
    Inclusion and exclusion criteria

    UACR 30 to 300 mg/g with eGFR 25 to 60 mL/min/1.73 m2 and diabetic retinopathy

    or

    UACR ≥300 mg/g with eGFR 25 to 75 mL/min/1.73 m2

    Inclusion and exclusion criteria
    Inclusion and exclusion criteria

    Exclusion

    Clinical diagnosis of chronic heart failure with reduced ejection fraction and persistent symptoms (New York Heart Association class II-IV)

    Known significant non-diabetic kidney disease

    Patient characteristics were well balanced between groups in the FIDELIO-DKD trial1,2

    Baseline

    Characteristics

    KERENDIA (n=2833) Placebo (n=2841)
    Race (% of patients)    
    White 62.7 63.9
    Black 4.9 4.4
    Asian 25.3 25.4
    Other 7.0 6.3
    Mean age (years) 65.4 65.7
    Male (% of patients) 68.9 71.5
    Mean eGFR (mL/min/1.73 m2) 44.4 44.3
    eGFR mL/min/1.73m2 (% of patients)    
    ≥60 11.2 11.9
    45 to <60 34.3 32.7
    25 to <45 52.1 53.0
    <25 2.3 2.4
    Median UACR (mg/g) 833 867
    Mean HbA1c (%) 7.7 7.7
    History of atherosclerotic CVD (% of patients) 46.0 45.8
    Select baseline medications (% of patients)    
    ACEi 33.5 34.9
    ARB 66.3 65.0
    Glucose-lowering therapies 97.0 97.7
    Insulin 65.1 63.1
    Metformin 44.2 43.6
    GLP-1 receptor agonists 6.7 7.2
    SGLT2 inhibitors 4.4 4.8
    Statins 74.3 74.3
    Antiplatelet agents 57.6 56.1

    14 patients were not treated with either an ACEi or an ARB at baseline; 7 patients received treatment with both an ACEi and an ARB.2

    ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; GLP-1=glucagon-like peptide-1; HbA1c=glycated hemoglobin; MI=myocardial infarction; NEJM=New England Journal of Medicine; SGLT2=sodium-glucose cotransporter 2; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

    INDICATION:

    KERENDIA is indicated to reduce the
    risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS:

    • Concomitant use with strong CYP3A4 inhibitors
    • Patients with adrenal insufficiency

    WARNINGS AND PRECAUTIONS:

    • Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L

       

      Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium

    MOST COMMON ADVERSE REACTIONS:

    • Adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo: hyperkalemia (18.3% vs. 9%), hypotension (4.8% vs. 3.4%), and hyponatremia (1.4% vs. 0.7%)

    DRUG INTERACTIONS:

    • Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice
    • Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate
    • Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers

    USE IN SPECIFIC POPULATIONS:

    • Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment
    • Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B)

    Please read the Prescribing Information for KERENDIA.

    References: 1. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2021. 2. Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. 3. Filippatos G, et al. Circulation. 2021;143(6):540-552.