ARR: 2.1% (95% CI: 0.4-3.8)2
NNT: 47 (95% CI: 26-226)
to prevent a primary composite endpoint event at 42 months2
For US healthcare providers
FIGARO-DKD (N=7352) and FIDELIO-DKD (N=5674) were randomized, double-blind, placebo-controlled, multicenter phase 3 trials with median follow-up periods of 3.4 and 2.6 years, respectively.1
CV Data
In adult patients with CKD associated with T2D
On top of standard of care, KERENDIA was proven to reduce the risk of CV events1-4
Figaro-DKD
Trial
Primary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF1
- The treatment effect was mainly driven by an effect on hospitalization for HF, though CV death also contributed1
- Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity4
- KERENDIA is not indicated to reduce the risk of nonfatal stroke1
The treatment effect was generally consistent across subgroups, including1,2:
SGLT2i use at baseline
GLP-1 use at baseline
UACR at baseline
eGFR at baseline
There were too few patients on SGLT2i and GLP-1 to draw meaningful conclusions.1,2
fidelio-DKD
Trial
Key secondary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF1
ARR: 2.4% (95% CI: 0.3-4.5)3
NNT: 42 (95% CI: 22-397)
to prevent a primary composite endpoint event at 36 months3
- The treatment effect reflected a reduction in CV death, nonfatal MI, and HHF1
- Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity4
- KERENDIA is not indicated to reduce the risk of nonfatal stroke1
Renal Data
In FIDELIO-DKD, adult patients with CKD associated with T2D
KERENDIA: Proven to slow CKD progression on top of standard of care1
Primary composite endpoint consisted of kidney failure,* sustained decline of ≥40% in eGFR, or renal death1
ARR: 3.4% (95% CI: 0.6-6.2)3
NNT: 29 (95% CI: 16-166)
to prevent a primary composite endpoint event at 36 months3
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
The treatment effect was generally consistent across subgroups, including1,3:
eGFR at baseline
UACR at baseline
SBP at baseline
HbA1c at baseline
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.2
Pharmacology
For adult patients with CKD associated with T2D
UACR reduction was observed with KERENDIA in clinical trials and real-world practice1-5
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 severity1-4
FIGARO-DKD6
FIDELIO-DKD3
In the FOUNTAIN observational, retrospective analysis of KERENDIA
UACR reduction was observed in real-world clinical practice5
FOUNTAIN ANALYSIS (N=15,948)
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 was 7.2 months.
FOUNTAIN LIMITATIONS
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)5
At month 12 (n=443)5
A total of 2137 patients had available UACR values at baseline and were included in the analysis of changes in UACR over time. The closest UACR measurement to baseline, 4 months and 12 months, respectively, was used. This was based on the following time windows5:
- Baseline (-90 to 0 days), 4 months (32 to 152 days), and 12 months (275 to 455 days)
- Patients with unknown or missing information were removed from this analysis
Select pharmacological properties and indications of MRAs1,7-10
*Based on preclinical animal models. The clinical consequences of these characteristics are unknown.8
†Active metabolite (half-life) = canrenone (16.5 hours), 7-α-thiomethylspirolactone (13.8 hours), 6-β-hydroxy-7-α-thiomethylspirolactone (15 hours).9
This chart represents select PK/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.
KERENDIA has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors1
SAFETY
Evaluated in >13,000 adult patients with CKD associated with T2D taking KERENDIA or placebo
KERENDIA has a generally well-tolerated safety profile1
Adverse reactions reported in ≥1% of patients taking KERENDIA and more frequently than placebo (pooled data from FIGARO-DKD and FIDELIO-DKD)1,4
Incidence of reproductive system and breast disorders was similar between KERENDIA and placebo, respectively4
Use in pregnancy: There are no available data on KERENDIA use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 2 times those expected in humans. The clinical significance of these findings is unclear.1
Initiation of KERENDIA may cause an initial small increase in blood creatinine levels (mean change <0.1 mg/dL) and a small decrease in eGFR (mean change 2 to 3 mL/min) that occurs within the first 4 weeks of starting therapy and then stabilizes. These changes were reversible after treatment discontinuation. Initiation of KERENDIA may also cause a small increase in serum uric acid. This increase appears to attenuate over time.1
TRIAL DESIGN
KERENDIA was evaluated in the largest CKD with T2D trial program to date4
>13,000 earlier-‡ and later-stage§ adult patients with CKD associated with T2D4
FIGARO-DKD and FIDELIO-DKD were randomized, double-blind, placebo-controlled, multicenter phase 3 trials with median follow-up periods of 3.4 and 2.6 years, respectively.2,3
CV outcomes trial
FIGARO-DKD1,2,11
(N=7328)
‡Majority earlier-stage (1-2) patients with CKD
(defined as eGFR ≥60 mL/min/1.73 m2 with albuminuria)
- Primary composite CV endpoint
- Secondary composite renal endpoint
Renal outcomes trial
FIDELIO-DKD1,3,11
(N=5662)
§Majority later-stage (3-4) patients with CKD
(defined as eGFR <60 mL/min/1.73 m2 with albuminuria)
- Primary composite renal endpoint
- Secondary composite CV endpoint
In both trials, patients were well managed with standard-of-care background therapy, including a maximum-tolerated dose of an ACEi or ARB, during a run-in period of 4 to 16 weeks.4
Trials had reciprocal endpoints (assessed in a time-to-event analysis)1
The CV composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HF hospitalization.
The renal composite endpoint consisted of kidney failure, sustained decline of ≥40% in eGFR, or renal death.
Select inclusion and exclusion criteria across both trials1
Select baseline characteristics2,3
Guidelines
In adult patients with CKD associated with T2D
KERENDIA is a fundamental, guidelines-recommended pillar of treatment1,11-18
Treatment strategy is based upon individual patient needs and physician discretion.
Multiple guidelines recommend KERENDIA1,11-18
Recommendations with an A rating are based on large, well-designed clinical trials or well-done meta-analyses. Generally, these recommendations have the best chance of improving outcomes when applied to the population to which they are appropriate. Level 1A recommendations are based on a randomized, controlled clinical trial. Level 2A recommendations are based on secular trends, such as those from correlational studies.
*At maximum-tolerated dose.15
AACE=American Association of Clinical Endocrinologists; ACEi=angiotensin-converting enzyme inhibitor; ADA=American Diabetes Association; ARB=angiotensin receptor blocker; ARR=absolute risk reduction; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; GLP-1=glucagon-like peptide-1; HbA1c=glycated hemoglobin; HF=heart failure; HF LVEF=heart failure with left ventricular ejection fraction; HFrEF=heart failure with reduced ejection fraction; HHF=hospitalization due to heart failure; HR=hazard ratio; KDIGO=Kidney Disease: Improving Global Outcomes; MI=myocardial infarction; MR=mineralocorticoid receptor; MRA=mineralocorticoid receptor antagonist; NNT=number needed to treat; NYHA=New York Heart Association; PD=pharmacodynamic; RA=receptor agonist; RRR=relative risk reduction; SBP=systolic blood pressure; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.
References:
- Kerendia (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc; July 2025.
- Pitt B, et al. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956.
- Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845.
- Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777.
- Kovesdy CP, et al. Nephron. Published online February 27, 2025:1-26. doi:10.1159/000543923.
- Ruilope LM, et al. Nephrol Dial Transplant. 2023;38(2):372-383.
- Kintscher U, et al. Br J Pharmacol. 2022;179(13):3220-3234. doi:10.1111/bph.15747.
- Kolkhof P, et al. Handb Exp Pharmacol. 2017;243:271-305. doi:10.1007/164_2016_76.
- Aldactone (spironolactone) [prescribing information]. New York, NY: Pfizer; September 2023.
- Inspra (eplerenone) [prescribing information]. New York, NY: Pfizer; August 2020.
- Kidney Disease: Improving Global Outcomes® (KDIGO), CKD Work Group. Kidney Int. 2024;105(4S):S117-S314. doi:10.1016/j.kint.2023.10.018.
- Blazek O. Am Heart J Plus. 2022;19:100187.
- de Boer IH, et al. Diabetes Care. 2022;45(12):3075-3090. doi:10.2337/dci22-0027.
- American Diabetes Association (Section 10: Cardiovascular disease and risk management: standards of care in diabetes). Diabetes Care. 2025;48(suppl 1):S207-S238. doi:10.2337/dc25-S010.
- American Diabetes Association (Section 11: Chronic kidney disease and risk management: standards of care in diabetes). Diabetes Care. 2025;48(suppl 1):S239-S251. doi:10.2337/dc25-S011.
- Blonde L, et al. Endocr Pract. 2022;28(10):923-1049. doi:10.1016/j.eprac.2022.08.002.
- McDonagh TA, et al. Eur Heart J. 2023;44(37):3627-3639. doi:10.1093/eurheartj/ehad195.
- Marx N, et al. Eur Heart J. 2023;44(39):4043-4140. doi:10.1093/eurheartj/ehad192.
- Quick Links
- FIGARO-DKD in NEJM
- FIDELIO-DKD in NEJM
- Dosing
INDICATIONS:
KERENDIA (finerenone) is indicated to reduce the risk of:
- sustained estimated glomerular filtration rate (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) (10mg, 20mg tablets)
- cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- Hypersensitivity to any component of this product
- 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 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.
Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed
Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function
MOST COMMON ADVERSE REACTIONS:
- CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, 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%), and hyponatremia (1.3% vs 0.7%).
- HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).
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.
- Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.
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 see the full Prescribing Information for KERENDIA.
