In adult patients with CKD associated with T2D

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

The FIDELIO-DKD trial was published in the New England Journal of Medicine

Patients icon

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
Calendar icon

4- to 16-week run-in period to adjust ACEi or ARB to the maximum tolerated labeled dose

Kidney icon

Primary composite endpoint consisted of:

  • End-stage kidney disease*
  • A sustained decline of ≥40% in eGFR
  • Renal death
Heartbeat icon

Key secondary composite endpoint consisted of:

  • CV death
  • Non-fatal MI
  • Non-fatal stroke
  • Hospitalization for heart failure

*End-stage kidney disease 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

Patient trial criteria

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

Patient characteristics graph

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.

KERENDIA significantly slowed CKD progression1

Primary composite endpoint consisted of end-stage kidney disease,* a sustained decline of ≥40% in eGFR from baseline over ≥4 weeks, or renal death.1

 

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 trial.1

Alt tag
Alt tag

Treatment effect was generally consistent across subgroups, including1,2:

  • eGFR at baseline
  • UACR at baseline
  • SBP at baseline
  • HbA1c at baseline

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

ARR=absolute risk reduction; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; HbA1c=glycated hemoglobin; HR=hazard ratio; NNT=number needed to treat; RRR=relative risk reduction; SBP=systolic blood pressure; UACR=urine albumin-to-creatinine ratio.

KERENDIA significantly reduced the risk of the CV composite endpoint1

Key secondary composite endpoint consisted of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure.1

 

The treatment effect reflected a reduction in CV death, non-fatal MI, and hospitalization for heart failure.1

Alt tag
Alt tag

Treatment effect was generally consistent across subgroups, including1-3:

  • eGFR at baseline
  • UACR at baseline
  • SBP at baseline
  • HbA1c at baseline
  • CVD history

IMPORTANT SAFETY INFORMATION AND INDICATION

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)

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)

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)

Please read the Prescribing Information for KERENDIA.

References:

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