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Bayer to present real-world study data of Kerendia (finerenone)
Bayer will present data on Kerendia™ (finerenone) use among patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in real-world clinical practice, as well as new risk models for patients with CKD and T2D at the 61st European Renal Association (ERA) Congress.
New models tested for the risk of chronic kidney disease (CKD) progression and onset of hyperkalaemia among patients with CKD and type 2 diabetes (T2D) / Efficacy of finerenone in reducing heart and kidney outcomes assessed among patients with differing risk of hyperkalaemia / Real-world study data on finerenone use among more than 28,000 patients with CKD and T2D. The data will include insights on how finerenone is used with other renal and cardiovascular protective medicines, and modelling with the aim to predict the long-term risk of CKD and potential onset of hyperkalemia.
Risk model for CKD progression
Accepted as a focused oral presentation, the study tests a new model using patient data from the FIDELITY pooled analysis. Developed by the CKD Prognosis Consortium (CKD-PC), it aims to predict the 3-year risk of a ≥40% decrease in estimated glomerular filtration rate (eGFR) or kidney failure in the general population:
- CKD-PC risk model for CKD Progression: Validation and association with outcomes in the FIDELITY population
Risk model for hyperkalaemia
Despite the positive data for use of finerenone among patients with CKD and T2D, perceived risk of hyperkalaemia may limit use, particularly in patients with high risk of increased serum potassium. A new risk score model was developed and validated using data from the FIDELITY analysis, and the efficacy of finerenone was also assessed among patients with differing levels of hyperkalaemia risk. The study was accepted as a late-breaker:
Despite the positive data for use of finerenone among patients with CKD and T2D, perceived risk of hyperkalaemia may limit use, particularly in patients with high risk of increased serum potassium. A new risk score model was developed and validated using data from the FIDELITY analysis, and the efficacy of finerenone was also assessed among patients with differing levels of hyperkalaemia risk. The study was accepted as a late-breaker:
- Hyperkalemia risk and the effect of finerenone in patients with diabetes and chronic kidney disease: an analysis from FIDELITY
Real-world clinical outcomes for finerenone
Building on clinical trial data demonstrating ability of finerenone to reduce the risk of cardiovascular and renal complications, real-world study data was obtained from US patients with CKD and T2D. The analysis of 28,056 health records and insurance claims is part of a multi-national, multi-database observational research platform:
Building on clinical trial data demonstrating ability of finerenone to reduce the risk of cardiovascular and renal complications, real-world study data was obtained from US patients with CKD and T2D. The analysis of 28,056 health records and insurance claims is part of a multi-national, multi-database observational research platform:
- Clinical outcomes in US patients initiating finerenone – a report from the FOUNTAIN platform
About the FIDELITY analysis
FIDELITY is a prespecified pooled analysis of more than 13,000 patients from the Phase III studies FIGARO-DKD and FIDELIO-DKD, investigating the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D.
About Kerendia™ (finerenone) / Firialta™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with T2D in more than 85 countries worldwide, including in China, Europe, Japan, and the U.S. The study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The THUNDERBALL CKD program consists of FIDELIO-DKD, FIGARO-DKD, FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, as well as the Phase II study CONFIDENCE. The MOONRAKER program includes FINEARTS-HF, REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF.
About Chronic Kidney Disease in Type 2 Diabetes
CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with T2D develop CKD. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 190 million people with T2D worldwide. CKD in T2D is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. Patients with CKD and T2D are three times more likely to die from a cardiovascular-related cause than those with T2D alone.
About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.
www.bayer.com
FIDELITY is a prespecified pooled analysis of more than 13,000 patients from the Phase III studies FIGARO-DKD and FIDELIO-DKD, investigating the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D.
About Kerendia™ (finerenone) / Firialta™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with T2D in more than 85 countries worldwide, including in China, Europe, Japan, and the U.S. The study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The THUNDERBALL CKD program consists of FIDELIO-DKD, FIGARO-DKD, FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, as well as the Phase II study CONFIDENCE. The MOONRAKER program includes FINEARTS-HF, REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF.
About Chronic Kidney Disease in Type 2 Diabetes
CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with T2D develop CKD. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 190 million people with T2D worldwide. CKD in T2D is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. Patients with CKD and T2D are three times more likely to die from a cardiovascular-related cause than those with T2D alone.
About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.
www.bayer.com
