WHIPPANY, N.J.– Bayer will present new cardiovascular (CV) and renal subgroup analyses for KERENDIA® (finerenone) from the comprehensive clinical trial program, including the FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from November 4-7, 2021. These data will be presented in scientific sessions in two oral presentations and two late-breaking posters, continuing to add to the growing body of data for patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
New Subgroup Analysis of Finerenone FIDELIO-DKD Data
The results of Bayer’s Phase III study FIDELIO-DKD were shared in October 2020 and simultaneously published in the New England Journal of Medicine. FIDELIO-DKD was the first trial in the finerenone Phase III clinical trial program, which evaluated finerenone in addition to standard of care (SoC) in patients with CKD associated with T2D for kidney-specific outcomes. The FIDELIO-DKD study met its primary and key secondary endpoint, which led to the July 9, 2021 FDA approval of KERENDIA 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 CKD associated with T2D.1 At the upcoming ASN Kidney Week 2021, Bayer will present new subgroup analysis from FIDELIO-DKD, which explored how changes in urine albumin-to-creatinine ratio (uACR) can impact cardiovascular and renal outcomes in patients with CKD associated with T2D.
- Association of Urine Albumin-to-Creatinine Ratio and Its Early Change with Cardiorenal Outcomes in FIDELIO-DKD: A Mediation Analysis
- November 4, 2021, 10 a.m. (PDT) / 6 p.m. (CEST)
- Session: Late-Breaking Clinical Trials Posters
- Poster: PO2531
Finerenone FIDELITY Prespecified Pooled Analysis Data
At the upcoming ASN Kidney Week 2021, Bayer will also present new findings from FIDELITY, the prespecified pooled analysis of both FIDELIO-DKD and FIGARO-DKD, which combines the trial populations of patients with CKD (stages 1-4) associated with T2D. This new analysis investigated the role of finerenone on renal outcomes by baseline therapy.
- Finerenone and Kidney Outcomes in Patients With CKD and T2D: Results From FIDELITY
- November 4, 2021, 10 a.m. (PDT) / 6 p.m. (CEST)
- Session: Late-Breaking Clinical Trials Posters
- Poster: PO2531
- Finerenone in Patients with CKD and Type 2 Diabetes by SGLT-2i Treatment: The FIDELITY Analysis (Abstract SA-OR22)
- November 6, 2021, 4:30-6:00 p.m. (PDT) / November 7, 12:30-2:00 a.m. (CEST)
- Session: OR0602. Diabetic Kidney Disease: Recent Advances
Finerenone FIGARO-DKD Study Data
The results of Bayer’s Phase III study FIGARO-DKD were shared in August 2021 and simultaneously published in the New England Journal of Medicine. At the upcoming ASN Kidney Week 2021, Bayer will present additional subgroup analysis from FIGARO-DKD examining the impact of finerenone on renal outcomes.
- Finerenone and Kidney Outcomes in Patients with CKD and Type 2 Diabetes: Results From FIGARO-DKD (Abstract SA-OR21)
- November 6, 2021, 4:30-6:00 p.m. (PDT) / November 7, 12:30-2:00 a.m. (CEST)
- Session: OR0602. Diabetic Kidney Disease: Recent Advances
The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.2 For more information, see “Important Safety Information” below.
