NCT05254002

A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,664 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD. Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine. In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone. Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times. The study team will: * collect blood and urine samples * check the participants' vital signs * do a physical examination including height and weight * check the participants' heart health by using an electrocardiogram (ECG) * monitor the participants' blood pressure * ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.

Conditions

• Type 2 Diabetes Mellitus
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Finerenone (BAY94-8862 ) 10 mg	oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: \<60 mL/min/1.73 m2
DRUG	Empagliflozin	oral administration, once daily
DRUG	Empagliflozin Placebo	Matching placebo to empagliflozin oral administration, once daily
DRUG	Finerenone (BAY94-8862 ) 20 mg	oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2
DRUG	Finerenone Placebo	Matching Placebo to Finerenone oral administration once daily

Timeline

• Start date: 2022-06-23
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2022-02-24
• Last updated: 2025-03-18

Locations

185 sites across 14 countries: United States, Belgium, Canada, Denmark, France, Germany, India, Israel, Italy, Japan, Netherlands, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study