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
- Conditions
- Type 2 Diabetes MellitusChronic Kidney Disease
- Interventions
- Registration Number
- NCT05254002
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1664
-
Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following:
- In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
- In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
- 100 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
-
Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
-
Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.
- Participants with type 1 diabetes (T1D).
- Participant with hepatic insufficiency classified as Child-Pugh C.
- Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolic blood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP lower than 90 mmHg.
- Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
- Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Finerenone and Empagliflozin Finerenone (BAY94-8862 ) 20 mg Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days. Finerenone and Empagliflozin placebo Empagliflozin Placebo Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days. Finerenone and Empagliflozin placebo Finerenone (BAY94-8862 ) 20 mg Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days. Finerenone and Empagliflozin placebo Finerenone (BAY94-8862 ) 10 mg Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days. Empagliflozin and Finerenone placebo Finerenone Placebo Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days. Finerenone and Empagliflozin Finerenone (BAY94-8862 ) 10 mg Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days. Finerenone and Empagliflozin Empagliflozin Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days. Empagliflozin and Finerenone placebo Empagliflozin Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.
- Primary Outcome Measures
Name Time Method Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone Upto 180 days Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone Up to 180 days Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone Up to 180 days Urinary albumin to-creatinine ratio (UACR)
Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone Up to 180 days
- Secondary Outcome Measures
Name Time Method Total number of ketoacidosis events Up to 180 days Proportion of participants with symptomatic hypotension events Up to 180 days Proportion of participants with necrotizing fasciitis of the perineum events Up to 180 days Proportion of participants with severe hypoglycemia events Up to 180 days Severe hypoglycemia is defined as glucose level of \<3.0 mmol/L (\<54 mg/dL).
Total number of events of severe hypoglycemia events 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) Up to 210 days Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1) Up to 210 days Relative change in UACR category (>30%, >40%, >50%) at 180 days Up to 180 days Ratio of change from baseline in eGFR at 30 days Up to 30 days estimated glomerular filtration rate (eGRF)
eGFR decline greater than 30% at 30 days from baseline Up to 30 days Proportion of participants with of acute kidney injury (AKI) events Up to 180 days 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 hoursTotal number of symptomatic hypotension events Up to 180 days Proportion of participants with genital mycotic events Up to 180 days Ratio of change in eGFR at 180 days and 210 days from Day 30 Up to 210 days Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L]) Up to 180 days serum/plasma potassium (k+)
Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L]) Up to 180 days Change from baseline in K+ Up to 180 days Proportion of participants with ketoacidosis events Up to 180 days Total number of necrotizing fasciitis of the perineum events Up to 180 days Proportion of participants with urosepsis and pyelonephritis events Up to 180 days Total number of genital mycotic events Up to 180 days Total number of urosepsis and pyelonephritis events Up to 180 days Total number of AKI events Up to 180 days
Trial Locations
- Locations (181)
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
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
Scroll for more (171 remaining)Southwest Kidney Institute, PLC🇺🇸Surprise, Arizona, United States