Simultaneous treatment start with Finerenone and SGLT-2-inhibitor demonstrated positive data in patients with CKD associated with type 2 diabetes: Bayer
Berlin: Bayer has announced results of the Phase II CONFIDENCE study, demonstrating that simultaneous initiation of finerenone (Kerendia) and the SGLT-2-inhibitor (SGLT-2i) empagliflozin led to a significantly greater reduction in urine albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) than with either treatment alone.
The findings were presented at the 62nd European Renal Association (ERA) Congress 2025 and simultaneously published in the New England Journal of Medicine.
The CONFIDENCE study showed that simultaneous initiation with finerenone and empagliflozin in patients with CKD associated with T2D led to an early and additive reduction in UACR from baseline of 52% at Day 180. This was a 29% and 32% greater relative reduction in UACR from baseline to Day 180 compared to finerenone alone and empagliflozin alone, respectively. Notably, a reduction of more than 30% in UACR was observed within 14 days of starting both treatments simultaneously – a threshold recommended by the American Diabetes Association (ADA) to slow kidney disease progression in patients with CKD*. Almost 3 out of 4 patients achieved this threshold of a 30% reduction in UACR versus baseline – 20% more than with either treatment alone. The safety profile of simultaneous initiation of finerenone and SGLT-2i was consistent with that of either agent alone, and treatment benefits were seen across all prespecified subgroups enrolled in the study, across a broad spectrum of patient populations with a high comorbidity burden.
Finerenone is marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.
The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes the completed Phase III study FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD and FIGARO-DKD and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies FIND-CKD, FIONA, FIONA-OLE, and FINE-ONE.
Reference:
Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes, Rajiv Agarwal, Jennifer B. Green, Hiddo J.L. Heerspink, DOI: 10.1056/NEJMoa2410659
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