Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE)

Green JB, Mottl AK, Bakris G, Heerspink HJL, Mann JFE, Mcgill JB, Nangaku M, Rossing P, Scott C, Gay A, Agarwal R (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Nephrology Dialysis Transplantation Oxford University Press (OUP): Policy B

DOI: 10.1093/ndt/gfac198

Abstract

Background Despite available interventions, people with type 2 diabetes (T2D) remain at risk of chronic kidney disease (CKD). Finerenone, a potent and selective nonsteroidal mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitors (SGLT2is) can reduce both kidney and cardiovascular risks in people with CKD and T2D. Here we outline the design of a study to investigate whether dual therapy with finerenone and an SGLT2i is superior to either agent alone. Methods CONFIDENCE (NCT05254002) is a randomized, controlled, double-blind, double-dummy, international, multicenter, three-armed, parallel-group, 7.5 - to 8.5-month, Phase 2 study in 807 adults with T2D, stage 2-3 CKD and a urine albumin:creatinine ratio (UACR) >= 300-<5000 mg/g. The primary objective is to demonstrate that 6 months of dual therapy comprising finerenone and the SGLT2i empagliflozin is superior for reducing albuminuria versus either agent alone. Interventions will be once-daily finerenone 10 mg or 20 mg (target dose) plus empagliflozin 10 mg, or empagliflozin 10 mg alone, or finerenone 10 mg or 20 mg (target dose) alone. Results The primary outcome is a relative change from baseline in UACR among the three groups. Secondary outcomes will further characterize efficacy and safety, including changes in estimated glomerular filtration rate and incident hyperkalemia. Conclusions CONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and an SGLT2i in adults with CKD and T2D. Should an additive effect be shown, early and efficient intervention with dual finerenone and SGLT2i therapy could slow disease progression and provide long-term benefits for people with CKD and T2D.

Involved external institutions

Duke University US United States (USA) (US) University of North Carolina at Chapel Hill US United States (USA) (US) University of Chicago Medical Center US United States (USA) (US) University of Groningen / Rijksuniversiteit Groningen NL Netherlands (NL) KfH Kuratorium für Dialyse und Nierentransplantation e.V. DE Germany (DE) Washington University in St. Louis US United States (USA) (US) University of Tokyo JP Japan (JP) Steno Diabetes Center DK Denmark (DK) Bayer Plc GB United Kingdom (GB) Bayer AG DE Germany (DE) Richard L Roudebush VA Medical Center US United States (USA) (US)

How to cite

APA:

Green, J.B., Mottl, A.K., Bakris, G., Heerspink, H.J.L., Mann, J.F.E., Mcgill, J.B.,... Agarwal, R. (2022). Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE). Nephrology Dialysis Transplantation. https://doi.org/10.1093/ndt/gfac198

MLA:

Green, Jennifer B., et al. "Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE)." Nephrology Dialysis Transplantation (2022).

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