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

Journal Article (Journal Article)

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 co-transporter 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 a SGLT2i is superior to either agent alone. METHODS: CONFIDENCE (NCT05254002) is a randomized, controlled, double-blind, double-dummy, international, multicentre, three-armed, parallel-group, 7.5-8.5-month, Phase 2 study in approximately 807 adults with T2D, stage 2-3 CKD and a urine albumin-to-creatinine ratio (UACR) from ≥ 300-<5000 mg/g. The primary objective is to demonstrate that 6 months' 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 relative change from baseline in UACR among the three groups. Secondary outcomes will further characterize efficacy and safety, including change in eGFR and incident hyperkalaemia. CONCLUSIONS: CONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and a 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.

Full Text

Duke Authors

Cited Authors

  • Green, JB; Mottl, AK; Bakris, G; Heerspink, HJL; Mann, JFE; McGill, JB; Nangaku, M; Rossing, P; Scott, C; Gay, A; Agarwal, R

Published Date

  • June 14, 2022

Published In

PubMed ID

  • 35700142

Electronic International Standard Serial Number (EISSN)

  • 1460-2385

Digital Object Identifier (DOI)

  • 10.1093/ndt/gfac198

Language

  • eng

Conference Location

  • England