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 (CONFIDENCE)

Bayer

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus

Treatments: Drug: Finerenone (BAY94-8862 ) 20 mg; Drug: Finerenone Placebo; Drug: Finerenone (BAY94-8862 ) 10 mg; Drug: Empagliflozin Placebo; Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05254002

2023-506981-30-00 (Registry Identifier)

21839

2021-003037-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 807 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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807 participants in 3 patient groups

Finerenone and Empagliflozin

Experimental group

Description:

Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days.

Treatment:

Drug: Empagliflozin

Drug: Finerenone (BAY94-8862 ) 10 mg

Drug: Finerenone (BAY94-8862 ) 20 mg

Finerenone and Empagliflozin placebo

Experimental group

Description:

Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.

Treatment:

Drug: Empagliflozin Placebo

Drug: Finerenone (BAY94-8862 ) 10 mg

Drug: Finerenone (BAY94-8862 ) 20 mg

Empagliflozin and Finerenone placebo

Experimental group

Description:

Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.

Treatment:

Drug: Empagliflozin

Drug: Finerenone Placebo