Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Kerendia 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 (T2DM). FDA label
Also known as Finerenone (BAY94-8862), Finerenone: 1, Finerenone Oral Tablet, Kerendia, Firialta
Finerenone · 19 trials · 15 indications
Hierarchical composite of the following: * Time to all-cause mortality * Number of total HF events * Time to first HF event * Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method
\- Serious AEs (excluding efficacy endpoints).
\- AEs leading to discontinuation of finerenone or empagliflozin.
\- Time to first CV death or HF event with finerenone compared to placebo.
\- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms.
UACR will be assessed by the Central laboratory.
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Percent change from baseline to day 180±7 in UPCR will be calculated.
eGFR: Estimated glomerular filtration rate
Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.
Count of participants and time from randomization to the first occurrence of the primary renal composite outcome, onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.
Signed consent by 30 participants for the main clinical trial within 3 months of launching the full study protocol (date of first person randomized).
Signed consent by 10 participants for the biopsy substudy within 3 months of launching the full study protocol (date of first person randomized).
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline, estimated using a mixed model for repeated measures. The treatment effect is expressed as the ratio of LS means for the combination therapy group compared with empagliflozin alone. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with chronic kidney disease and type 2 diabetes.
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline in the combination therapy group compared with finerenone alone, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a measurement of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2\^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration.
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
AUC for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Cmax for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
AUCu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Cmax,u BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
AUCnorm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
AUCu, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Cmax, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Cmax,u,norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
| Arm | Type | Description |
|---|---|---|
| Finerenone plus empagliflozin | EXPERIMENTAL | - |
| Usual care | NO_INTERVENTION | Usual care management |
| Finerenone | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Finerenone Open-Label Safety Extension | EXPERIMENTAL | Participants will receive finerenone treatment. |
| Finerenone (Kerendia, BAY94-8862) | EXPERIMENTAL | Participants will receive finerenone treatment. |
| Finerenone arm | EXPERIMENTAL | Participants with eGFR ≥25 to \<60 mL/min/1.73 m\^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m\^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months. |
| Placebo arm | PLACEBO_COMPARATOR | Participants will take Finerenone matching placebo for 6 months. |
| Finerenone (BAY94-8862) | EXPERIMENTAL | Participants will receive finerenone. |
| Arm 1_BAY94-8862 | EXPERIMENTAL | Adult patients receive BAY94-8862 |
| Arm 2_Placebo | PLACEBO_COMPARATOR | Adult patients receive placebo |
| BAY94-8862 | EXPERIMENTAL | Finerenone tablet |
| Finerenone and Empagliflozin | EXPERIMENTAL | Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days. |
| Finerenone and Empagliflozin placebo | EXPERIMENTAL | Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days. |
| Empagliflozin and Finerenone placebo | EXPERIMENTAL | Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days. |
| Finerenone(BAY94-8862)[2.5mg] + Placebo | EXPERIMENTAL | Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. |
| Finerenone (BAY94-8862)[5mg] + Placebo | EXPERIMENTAL | Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. |
| Finerenone (BAY94-8862)[7.5mg] + Placebo | EXPERIMENTAL | Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. |
| Finerenone (BAY94-8862)[10mg] + Placebo | EXPERIMENTAL | Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. |
| Finerenone (BAY94-8862)[15mg] + Placebo | EXPERIMENTAL | Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. |
| Eplerenone [25 mg] + Placebo | ACTIVE_COMPARATOR | Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days. |
| Finerenone (BAY94-8862) (1.25 mg) | EXPERIMENTAL | 1.25 mg dose oral once daily for 90 days |
| Finerenone (BAY94-8862)(2.5 mg) | EXPERIMENTAL | 2.5 mg dose oral once daily for 90 days |
| Finerenone (BAY94-8862)(5 mg) | EXPERIMENTAL | 5 mg dose oral once daily for 90 days |
| Finerenone (BAY94-8862)(7.5 mg) | EXPERIMENTAL | 7.5 mg dose oral once daily for 90 days |
| Finerenone (BAY94-8862) (10 mg) | EXPERIMENTAL | 10 mg dose oral once daily for 90 days |
| Finerenone (BAY94-8862) (15 mg) | EXPERIMENTAL | 15 mg dose oral once daily for 90 days |
| Finerenone (BAY94-8862)(20 mg) | EXPERIMENTAL | 20 mg dose oral once daily for 90 days |
| Mild hepatic impairment (Child Pugh A) | EXPERIMENTAL | Participants with mild hepatic impairment (Child Pugh A) received single oral dose of finerenone. |
| Moderate hepatic impairment (Child Pugh B) | EXPERIMENTAL | Participants with moderate hepatic impairment (Child Pugh B) received single oral dose of finerenone. |
| Healthy participants | EXPERIMENTAL | Healthy age-, weight-, and gender- matched participants received single oral dose of finerenone. |
| Normal renal function | EXPERIMENTAL | Healthy participants with creatinine clearance (CLCR) \>80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
| Mild renal impairment | EXPERIMENTAL | Participants with CLCR 50-80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
| Moderate renal impairment | EXPERIMENTAL | Participants with CLCR 30-\<50 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
| Severe renal impairment | EXPERIMENTAL | Participants with CLCR \<30 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
| Name | Type | Description |
|---|---|---|
| Finerenone | DRUG | Oral finerenone. |
| Empagliflozin | DRUG | Oral empagliflozin. |
| Placebo | DRUG | Matching oral placebo. |
| Finerenone (Kerendia, BAY94-8862) | DRUG | Finerenone in different doses, treatment duration will be 270±7 days. |
| Finerenone (BAY94-8862) | DRUG | Tablet, 10 mg or 20 mg, once daily (OD), oral |
| Finerenone Oral Tablet | DRUG | Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels. |
| Finerenone (BAY94-8862 ) 10 mg | DRUG | oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: \<60 mL/min/1.73 m2 |
| Empagliflozin Placebo | DRUG | Matching placebo to empagliflozin oral administration, once daily |
| Finerenone (BAY94-8862 ) 20 mg | DRUG | oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2 |
| Finerenone Placebo | DRUG | Matching Placebo to Finerenone oral administration once daily |
| Inspra (eplerenone) | DRUG | - |
Inclusion Criteria: * Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations * Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence * Current hospitalization or rec...
Finerenone is an oral small molecule drug developed by Bayer AG for chronic kidney disease, diabetic kidney disease, diabetic nephropathies, heart failure, kidney transplant complications, and left ventricular systolic dysfunction. It is also known as Kerendia or BAY94-8862. Finerenone is in Phase 3 clinical development across these indications.
Finerenone targets NR3C2, also known as the mineralocorticoid receptor. It acts as an antagonist at this receptor. By blocking NR3C2, finerenone is designed to reduce the effects of aldosterone and mineralocorticoid signaling, which are implicated in kidney and heart disease.
Finerenone is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer AG is responsible for the clinical development and regulatory activities for finerenone across its studied indications.
Finerenone is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for the indications listed. The Phase 3 program includes trials in heart failure and pediatric heart failure, while a Phase 2 trial is ongoing in kidney transplant recipients.
Finerenone is being studied in several clinical trials. These include NCT07192952 and NCT07188805, both Phase 3 trials in children and young adults with heart failure and left ventricular systolic dysfunction. NCT06033950 is a Phase 3 trial in adults with heart failure. NCT06059664 is a Phase 2 trial in kidney transplant recipients.
Yes, finerenone is also known by the brand name Kerendia and the developmental code BAY94-8862. Other names include finerenone oral tablet and finerenone 10 mg tablet. These all refer to the same active drug developed by Bayer AG.