In adult patients with CKD associated with T2D
On top of standard of care, KERENDIA was proven to reduce the risk of CV events1,23,31
Primary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF23
- 2.1% ARR31 (95% CI: 0.4-3.8)
- NNT: 4731(95% CI: 26-266)to prevent a primary compositeendpoint event
- at 42 months
The treatment effect was mainly driven by an effect on hospitalization for HF, though CV death also contributed.23
Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity.1
KERENDIA is not indicated to reduce the risk of nonfatal stroke.23
Key secondary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF23
- 2.4% ARR10 (95% CI: 0.3-4.5)
- NNT: 4210(95% CI: 22-397)to prevent a primary compositeendpoint event
- at 36 months
The treatment effect reflected a reduction in CV death, nonfatal MI, and HHF.23
Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity.1
KERENDIA is not indicated to reduce the risk of nonfatal stroke.23
Expert insights on the impact of early CKD identification in patients with T2D
Dr. Javier Morales explains the consequences of CKD associated with T2D, and the crucial need to diagnose and treat patients earlier in their disease progression.
In adult patients with CKD associated with T2D
KERENDIA: Proven to slow CKD progression on top of standard of care23
Primary composite endpoint consisted of kidney failure,* sustained decline of ≥40% in eGFR, or renal death23
- 3.4% ARR10 (95% CI: 0.6-6.2)
- NNT: 2910(95% CI: 16-166)to prevent a primary compositeendpoint event
- at 36 months
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.23
Renal outcomes from FIGARO-DKD
The key secondary composite outcome of kidney failure, sustained eGFR decline of ≥40%, or renal death occurred in 350 patients in the KERENDIA group (9.5%) and 395 patients in the placebo group (10.8%) (HR=0.87 [95% CI: 0.76-1.01]). The difference was not statistically significant.31
In an exploratory analysis of adult patients with CKD associated with T2D
On top of standard of care, KERENDIA reduced UACR relative to placebo across a broad range of CKD severity1,10,23,31
FIGARO-DKD TRIAL34
FIDELIO-DKD TRIAL10
In the FOUNTAIN observational, retrospective analysis of KERENDIA
UACR reduction was observed in real-world clinical practice27
FOUNTAIN ANALYSIS (N=15,948)27
A descriptive, single-cohort retrospective analysis focused on new users of KERENDIA in the United States. FOUNTAIN data were sourced from the US electronic health records (OM1 Real World Data Cloud), which aggregated electronic health records with open claims and laboratory data
FOUNTAIN population included patients diagnosed with CKD and T2D who initiated treatment with KERENDIA
FOUNTAIN period spanned from July 9, 2021, to August 16, 2023; the cohort size was 15,948 patients; the median follow-up period was 7.2 months
FOUNTAIN Limitations27
A retrospective assessment based on health records may have missing or erroneous data entry
Dosing information and background therapy were not collected as part of the study
At month 4 (n=913):
At month 12 (n=443):
A total of 2137 patients had available UACR values at baseline and were included in the analysis of changes in UACR over time.27
The closest UACR measurement to baseline, 4 months, and 12 months, respectively, was used. This was based on the following time windows27:
- Baseline (-90 to 0 days), 4 months (32 to 152 days), 12 months (275 to 455 days)
- Patients with unknown or missing information were removed from this analysis
Pharmacological properties and indications of MRAs2,19,23-25,37
This chart represents select PD parameters. Please see the respective Prescribing Information for each product for complete product information. This chart does not imply a comparison of safety or efficacy data.
The FDA has categorized KERENDIA (finerenone) in its own drug class as a nonsteroidal mineralocorticoid receptor antagonist23
ARR=absolute risk reduction; CKD=chronic kidney disease; CV=cardiovascular; HHF=hospitalization for heart failure; HF=heart failure; HR=hazard ratio; MI=myocardial infarction; NNT=number needed to treat; RRR=relative risk reduction; T2D=type 2 diabetes.
*Kidney failure was defined as chronic dialysis or kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m2.23
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; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.
CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; HFrEF=heart failure with reduced ejection fraction; HHF=hospitalization for heart failure; MI=myocardial infarction; MR=mineralocorticoid receptor; MRA=mineralocorticoid receptor antagonist; NYHA=New York Heart Association; PD=pharmacodynamic; 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:
- From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3.9%), and hyponatremia (1.3% 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.
