A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.
Inclusion Criteria:
Men or women ≥18 years of age
Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:
Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:
Serum potassium ≤4.8 mmol/L at both the run-in and the screening visit
Exclusion Criteria:
CABA, Ciudad Auton. de Buenos Aires C1018DES, Argentina
Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires C1425AGC, Argentina
Saint Stefan, Styria 8511, Austria
Bruxelles - Brussel, 1070, Belgium
Paraná, Paraná 83430-000, Brazil
Smith Falls, Ontario K7A 4W8, Canada
Baranquilla, Atlántico 080020, Colombia
Monza Brianza, Lombardy 20832, Italy
Nakagami-gun, Okinawa 901-2393, Japan
Shibuya-ku, Tokyo 150-0002, Japan
Kelantan, 15200, Malaysia
Kelantan, Malaysia
México D.F., Mexico City 14080, Mexico
Puerto de Veracruz, Veracruz 91900, Mexico
Hawkes Bay, 4130, New Zealand
Lenasia South, Gauteng 1835, South Africa
Petoria, Gauteng, South Africa
Incheon Gwangyeogsi,, Incheon Gwang''yeogsi 21431, South Korea