(21177) A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease

Conditions

Non-diabetic chronic kidney disease

Brief summary

Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.

Detailed description

Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death, Time to the composite of kidney failure or sustained eGFR decline of >=57%, Time to the composite to heart failure hospitalization or CV death, Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI)

Hiddo J.L. Heerspink, Rajiv Agarwal, George L. Bakris, David Z.I. Cherney, Carolyn S.P. Lam et al. (100 authors)

Nephrology Dialysis Transplantation2024-06-1159 citations

10.1093/ndt/gfae132

Interventions

DRUGFinerenone

DRUGPlacebo

DRUGBAY 94-8862

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.	—

Secondary

Measure	Time frame
Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death, Time to the composite of kidney failure or sustained eGFR decline of >=57%, Time to the composite to heart failure hospitalization or CV death, Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI)	—

Measure

Time frame

Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death, Time to the composite of kidney failure or sustained eGFR decline of >=57%, Time to the composite to heart failure hospitalization or CV death, Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI)

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Countries

Belgium, Bulgaria, Czechia, Denmark, Greece, Hungary, Italy, Portugal, Spain

Outcome results

None listed