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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,664
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: \<60 mL/min/1.73 m2
oral administration, once daily
Matching placebo to empagliflozin oral administration, once daily
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2
Matching Placebo to Finerenone oral administration once daily
Southwest Kidney Institute, PLC
Surprise, Arizona, United States
Academic Medical Research Institute
Los Angeles, California, United States
Northridge Hospital
Northridge, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Touro University California
Vallejo, California, United States
Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone
Urinary albumin to-creatinine ratio (UACR)
Time frame: Up to 180 days
Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone
Time frame: Up to 180 days
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone
Time frame: Upto 180 days
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone
Time frame: Up to 180 days
Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)
Time frame: Up to 210 days
Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)
Time frame: Up to 210 days
Relative change in UACR category (>30%, >40%, >50%) at 180 days
Time frame: Up to 180 days
Ratio of change from baseline in eGFR at 30 days
estimated glomerular filtration rate (eGRF)
Time frame: Up to 30 days
eGFR decline greater than 30% at 30 days from baseline
Time frame: Up to 30 days
Ratio of change in eGFR at 180 days and 210 days from Day 30
Time frame: Up to 210 days
Proportion of participants with of acute kidney injury (AKI) events
AKI is defined as any of the following: * An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or * An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * A urine volume less than 0.5 ml/kg/h for 6 hours
Time frame: Up to 180 days
Total number of AKI events
Time frame: Up to 180 days
Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
serum/plasma potassium (k+)
Time frame: Up to 180 days
Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
Time frame: Up to 180 days
Change from baseline in K+
Time frame: Up to 180 days
Proportion of participants with severe hypoglycemia events
Severe hypoglycemia is defined as glucose level of \<3.0 mmol/L (\<54 mg/dL).
Time frame: Up to 180 days
Total number of events of severe hypoglycemia events
Time frame: Up to 180 days
Proportion of participants with symptomatic hypotension events
Time frame: Up to 180 days
Total number of symptomatic hypotension events
Time frame: Up to 180 days
Proportion of participants with genital mycotic events
Time frame: Up to 180 days
Total number of genital mycotic events
Time frame: Up to 180 days
Proportion of participants with ketoacidosis events
Time frame: Up to 180 days
Total number of ketoacidosis events
Time frame: Up to 180 days
Proportion of participants with necrotizing fasciitis of the perineum events
Time frame: Up to 180 days
Total number of necrotizing fasciitis of the perineum events
Time frame: Up to 180 days
Proportion of participants with urosepsis and pyelonephritis events
Time frame: Up to 180 days
Total number of urosepsis and pyelonephritis events
Time frame: Up to 180 days
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Chase Medical Research, LLC
Waterbury, Connecticut, United States
Florida Kidney Physicians - Delray Beach Nephrology
Delray Beach, Florida, United States
West Orange Endocrinology & Clinical Research
Ocoee, Florida, United States
Innovative Research Institute
Port Charlotte, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
...and 175 more locations