What Is Finerenone (Kerendia, BAY948862)?
Finerenone, known by its brand name Kerendia and investigational code BAY948862, is a medication studied in patients with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D). The provided trial descriptions do not detail the specific mechanism of action of finerenone. Instead, they describe how data is collected in observational studies, such as through retrospective cohort analyses using medical records or electronic health record (EHR) data. These studies gather information on patient demographics, clinical characteristics, diagnoses, treatments, and laboratory results related to finerenone use.
Finerenone is being investigated for its use in managing chronic kidney disease in patients who also have Type 2 diabetes. Observational studies involving finerenone analyze data from patients who are already receiving this treatment as part of their routine medical care. All 4 trials related to finerenone are sponsored by Bayer.
Uses and Conditions Under Study
Finerenone (Kerendia) is currently being studied for its use in two closely related conditions: chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D). All 4 trials for finerenone investigate both of these conditions.
Type 2 diabetes mellitus is a condition where glucose (sugar) levels in the blood become too high. It is one of the common causes of chronic kidney disease and can potentially lead to kidney failure. Chronic kidney disease is a long-term condition that affects the kidneys' ability to filter waste from the blood.
Observational studies involving finerenone collect and analyze existing data from patients who have both chronic kidney disease and Type 2 diabetes. These studies aim to understand how finerenone is used in clinical practice and its effects on patients in real-world settings. Data is gathered from various sources, including medical records and large healthcare databases, to observe patient outcomes without making any changes to their ongoing healthcare.
The total enrollment across all studies for finerenone is substantial, with 173,685 participants. The first trial began on January 30, 2023, and the latest trial is expected to conclude by August 15, 2025.
Dosing
Information regarding the specific dosage forms, strengths, and administration instructions for finerenone (Kerendia) is not detailed in the provided trial data. The trial descriptions indicate that dosage forms are to be found in individual trial protocols. The studies described are observational, meaning they collect data from patients who are already receiving finerenone as part of their routine medical care, following established clinical practice and administration guidelines.
Therefore, details such as whether finerenone is available as tablets or oral solutions, the specific strengths studied, how frequently it is taken (e.g., once or twice daily), or whether there are distinct adult versus pediatric dosing recommendations, are not available from the provided information.
Side Effects
The most common side effect reported with Finerenone (Kerendia, BAY948862) was elevated potassium levels in the blood (hyperkalemia). In clinical trials, 10.8% of patients taking Finerenone (Kerendia, BAY948862) experienced hyperkalemia, compared to 5.3% on placebo.
Other side effects reported in clinical studies, in order of frequency, include:
- Hypotension (low blood pressure): 4.8% of patients taking Finerenone (Kerendia, BAY948862) experienced this, compared to 3.1% on placebo.
- Hyponatremia (low sodium levels): 1.4% of patients taking Finerenone (Kerendia, BAY948862) experienced this, compared to 1.2% on placebo.
- Decreased glomerular filtration rate (a measure of kidney function): 1.4% of patients taking Finerenone (Kerendia, BAY948862) experienced this, compared to 0.7% on placebo.
- Anemia (low red blood cell count): 1.3% of patients taking Finerenone (Kerendia, BAY948862) experienced this, compared to 1.1% on placebo.
- Nausea: 1.3% of patients taking Finerenone (Kerendia, BAY948862) experienced this, compared to 1.2% on placebo.
- Increased serum creatinine (a marker of kidney function): 1.0% of patients taking Finerenone (Kerendia, BAY948862) experienced this, compared to 0.4% on placebo.
Clinical Trial Results
Chronic Kidney Disease and Type 2 Diabetes (FIDELIO-DKD and FIGARO-DKD)
The effectiveness of Finerenone (Kerendia, BAY948862) in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) was evaluated in two large, placebo-controlled studies, FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049).
In the FIDELIO-DKD study, Finerenone (Kerendia, BAY948862) significantly reduced the risk of kidney disease progression and kidney-related death. A composite outcome of kidney failure, a sustained decrease in kidney function (eGFR) by 40% or more, or renal death occurred in 17.8% of patients treated with Finerenone (Kerendia, BAY948862), compared to 21.1% of patients on placebo. Finerenone (Kerendia, BAY948862) also reduced the risk of major cardiovascular events. A composite outcome of cardiovascular death, non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure occurred in 13.0% of patients taking Finerenone (Kerendia, BAY948862), compared to 14.8% on placebo.
The FIGARO-DKD study primarily focused on cardiovascular outcomes. It showed that Finerenone (Kerendia, BAY948862) reduced the risk of major cardiovascular events, with 12.4% of patients on Finerenone (Kerendia, BAY948862) experiencing the composite of cardiovascular death, non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure, compared to 14.1% on placebo. While a reduction in kidney-related events was observed (8.1% with Finerenone (Kerendia, BAY948862) vs 8.8% with placebo), this difference did not reach statistical significance in this particular trial.
Diabetic Kidney Disease (ARTS-DN)
In the ARTS-DN study (NCT01802320), Finerenone (Kerendia, BAY948862) was investigated for its effects on diabetic kidney disease. Patients receiving Finerenone (Kerendia, BAY948862) showed a significant reduction in urine albumin-to-creatinine ratio (UACR), a marker of kidney damage. Patients on 10mg of Finerenone (Kerendia, BAY948862) experienced a 21% reduction in UACR, while those on 20mg saw a 32% reduction, compared to no significant change in the placebo group.
Heart Failure with Reduced Ejection Fraction and Chronic Kidney Disease (ARTS-HF)
The ARTS-HF study (NCT01877388) explored the effects of Finerenone (Kerendia, BAY948862) in patients with heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease. Finerenone (Kerendia, BAY948862) led to a dose-dependent reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker for heart failure. Patients on 10mg of Finerenone (Kerendia, BAY948862) had a 25% reduction in NT-proBNP, and those on 20mg had a 35% reduction, compared to a 5% reduction in the placebo group. The study also noted an increase in potassium levels, consistent with the known side effect of hyperkalemia.
Currently Recruiting Trials
At this time, there are no clinical trials for Finerenone (Kerendia, BAY948862) actively recruiting new participants. This means there are currently no opportunities to enroll in a study for this medication.
Where to Participate
As there are no clinical trials for Finerenone (Kerendia) currently recruiting, there are no active study sites or locations available for participation. If trials were recruiting, general eligibility criteria would typically include all genders, with no specific age range provided in the available data. It is important to note that these trials would not be seeking healthy volunteers or children, focusing instead on individuals with specific medical conditions.
Development Timeline
The journey of Finerenone (Kerendia, BAY948862) in clinical development began on January 30, 2023, with the first trial initiated by its sponsor, Bayer. The development pipeline for Finerenone initially focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the research expanded to explore its potential in other areas.
To date, a total of 4 trials have been conducted for Finerenone, involving a substantial number of participants, with a cumulative enrollment of 173,685 individuals. While specific phase details for each of these four trials are not specified in the available data, the significant enrollment numbers reflect extensive investigation into the drug's effects. The latest recorded trial for Finerenone is projected to conclude by August 15, 2025, indicating ongoing research and commitment from Bayer to understanding its full therapeutic potential.