What side effects are associated with this type of intervention?

Finerenone, a mineralocorticoid receptor blocker, has been associated with an increased risk of hyperkalemia, which can lead to discontinuation of the treatment in some cases. Empagliflozin, an SGLT2 inhibitor, primarily lowers blood sugar levels but can also cause side effects such as urinary tract infections and genital infections due to increased glucose excretion in the urine. Both treatments are generally well-tolerated, but monitoring for these specific adverse events is important.

What prior FDA approvals exist?

Finerenone, a mineralocorticoid receptor blocker, has been approved by the FDA for the treatment of CKD in patients with type 2 diabetes, as it helps reduce the risk of kidney function decline and cardiovascular events. Empagliflozin, an SGLT2 inhibitor, is also FDA-approved for CKD management in type 2 diabetes patients, as it lowers blood sugar levels and provides renal and cardiovascular benefits. Other SGLT2 inhibitors like Canagliflozin and Dapagliflozin have similarly been approved for CKD treatment due to their efficacy in slowing kidney disease progression and reducing cardiovascular risks.

What other types of research exist?

Promising novel alternatives to Finerenone and Empagliflozin for CKD patients include Apararenone, a non-steroidal mineralocorticoid receptor antagonist, and Dapagliflozin, another SGLT2 inhibitor. Additionally, Glucagon-like peptide-1 (GLP-1) receptor agonists such as Semaglutide and Liraglutide have shown potential in improving renal outcomes in patients with type 2 diabetes and CKD.

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SGLT2 Inhibitor

Finerenone + Empagliflozin for Chronic Kidney Disease and Type 2 Diabetes (CONFIDENCE Trial)

Phase 2

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.

300 ≤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

Must not have

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.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 180 days

Awards & highlights

Summary

This trial tests if combining finerenone and empagliflozin can better slow down kidney damage in patients with CKD and T2D compared to using each drug alone. Finerenone protects kidneys, while empagliflozin lowers blood sugar. Empagliflozin has shown significant improvements in glycemic control, body weight, and blood pressure, and finerenone has demonstrated improved outcomes in patients with chronic kidney disease and type 2 diabetes. The study will measure protein levels in urine to assess effectiveness.

Who is the study for?

Adults with chronic kidney disease and type 2 diabetes can join this trial. They should have a certain level of protein in their urine, stable kidney function within specific limits, and controlled blood sugar levels. Participants must be on ACE inhibitors or ARBs for at least a month but not both. Those with very high or low blood pressure, severe liver issues, or taking certain other medications are excluded.

What is being tested?

The study tests how well finerenone combined with empagliflozin works compared to each one alone in slowing down kidney function decline in participants. It measures the effect by checking protein levels in urine while maintaining other CKD and T2D treatments over a period of up to 7.5 months.

What are the potential side effects?

Possible side effects include changes in blood pressure, potassium levels that could affect heart rhythm (monitored via ECG), dehydration due to increased glucose excretion into the urine, and potential risks associated with long-term use such as worsening of kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have type 2 diabetes with an HbA1c level below 11%.

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My urine tests show high protein levels, confirmed over the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking certain heart or blood pressure medicines that can't be stopped for 8 weeks.

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I am currently on or cannot stop taking SGLT2i medication for 8 weeks before the study starts.

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My liver is not working well (Child-Pugh C).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone

Secondary study objectives

Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])

Proportion of participants with of acute kidney injury (AKI) events

Proportion of participants with severe hypoglycemia events

+1 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951

15%

Cardiac failure

Hypotension

Hypertension

Urinary tract infection

Hyperkalaemia

Renal impairment

Fall

Atrial fibrillation

Diabetes mellitus

Hyperuricaemia

Anaemia

Pneumonia

Acute kidney injury

Death

COVID-19

Acute myocardial infarction

Cardiac failure congestive

Syncope

Cardiac failure chronic

Chronic kidney disease

COVID-19 pneumonia

Coronary artery disease

Cellulitis

Basal cell carcinoma

Ischaemic stroke

Chronic obstructive pulmonary disease

Myocardial infarction

Sepsis

Transient ischaemic attack

Angina unstable

Cerebrovascular accident

Angina pectoris

Ventricular tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Empagliflozin

Trial Design

3Treatment groups

Experimental Treatment

Group I: Finerenone and Empagliflozin placeboExperimental Treatment3 Interventions

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

Group II: Finerenone and EmpagliflozinExperimental Treatment3 Interventions

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

Group III: Empagliflozin and Finerenone placeboExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin

2017

Completed Phase 4

~181750

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Finerenone, a mineralocorticoid receptor blocker, reduces kidney injury and inflammation by inhibiting the action of mineralocorticoid receptors, which are implicated in kidney damage when overstimulated. Empagliflozin, an SGLT2 inhibitor, lowers blood sugar by increasing glucose excretion in the urine, thereby reducing the kidneys' workload and improving kidney function. These treatments are crucial for CKD patients as they target different mechanisms that contribute to disease progression, potentially slowing it down and enhancing kidney health.

Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using an UACR Endpoint study (CONFIDENCE).Efficacy and safety of finerenone in patients with chronic kidney disease: a systematic review with meta-analysis and trial sequential analysis.