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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).

Publication ,  Journal Article
Green, JB; Mottl, AK; Bakris, G; Heerspink, HJL; Mann, JFE; McGill, JB; Nangaku, M; Rossing, P; Scott, C; Gay, A; Agarwal, R
Published in: Nephrol Dial Transplant
March 31, 2023

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.

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Published In

Nephrol Dial Transplant

DOI

EISSN

1460-2385

Publication Date

March 31, 2023

Volume

38

Issue

4

Start / End Page

894 / 903

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Renal Insufficiency, Chronic
  • Humans
  • Diabetic Nephropathies
  • Diabetes Mellitus, Type 2
  • 3202 Clinical sciences
  • 1103 Clinical Sciences
 

Citation

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Green, J. B., Mottl, A. K., Bakris, G., Heerspink, H. J. L., Mann, J. F. E., McGill, J. B., … Agarwal, R. (2023). 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). Nephrol Dial Transplant, 38(4), 894–903. https://doi.org/10.1093/ndt/gfac198
Green, Jennifer B., Amy K. Mottl, George Bakris, Hiddo J. L. Heerspink, Johannes F. E. Mann, Janet B. McGill, Masaomi Nangaku, 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).Nephrol Dial Transplant 38, no. 4 (March 31, 2023): 894–903. https://doi.org/10.1093/ndt/gfac198.
Green JB, Mottl AK, Bakris G, Heerspink HJL, Mann JFE, McGill JB, 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). Nephrol Dial Transplant. 2023 Mar 31;38(4):894–903.
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).Nephrol Dial Transplant, vol. 38, no. 4, Mar. 2023, pp. 894–903. Pubmed, doi:10.1093/ndt/gfac198.
Green JB, Mottl AK, Bakris G, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rossing P, Scott C, Gay A, Agarwal R. 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). Nephrol Dial Transplant. 2023 Mar 31;38(4):894–903.
Journal cover image

Published In

Nephrol Dial Transplant

DOI

EISSN

1460-2385

Publication Date

March 31, 2023

Volume

38

Issue

4

Start / End Page

894 / 903

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Renal Insufficiency, Chronic
  • Humans
  • Diabetic Nephropathies
  • Diabetes Mellitus, Type 2
  • 3202 Clinical sciences
  • 1103 Clinical Sciences