At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7,352 enrolled
Drug / intervention
Finerenone (BAY94-8862) +1 moredrug
Likely dose
Finerenone (BAY94-8862) 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
In Brief
A Phase 3 clinical trial evaluating Finerenone (BAY94-8862) and Placebo for Diabetic Kidney Disease. Completed, enrolled 7,352 participants across 975 sites in 48 countries.
Detailed Summary
The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Kidney Disease
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartSep 2015
Primary CompletionFeb 2021
TodayJul 2026
First PostedSep 9, 2015
Enrollment StartSep 17, 2015
Primary CompletionFeb 2, 2021
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 10.8 years ago
Interventions
Finerenone (BAY94-8862)drug
10 mg or 20 mg Finerenone tablet to be given orally, once daily.
Placebodrug
Matching placebo to be taken orally, once daily.