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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 210 days
Awards & highlights

CONFIDENCE Trial Summary

This trial is investigating whether the combination of finerenone and empagliflozin is more effective and safe than either treatment alone in slowing the worsening of kidney function in people with CKD and T2D.

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.Check my eligibility
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.See study design
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.

CONFIDENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 2 diabetes with an HbA1c level below 11%.
Select...
My urine tests show high protein levels, confirmed over the last 3 months.

CONFIDENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 210 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 210 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone
Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone
+1 more
Secondary outcome measures
Change from baseline in K+
Proportion of participants with genital mycotic events
Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
+20 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951
15%
Cardiac failure
7%
Hypertension
7%
Urinary tract infection
7%
Hypotension
6%
Hyperkalaemia
6%
Fall
6%
Renal impairment
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Anaemia
4%
Hyperuricaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Acute myocardial infarction
2%
COVID-19
2%
Cardiac failure congestive
2%
Death
1%
Myocardial infarction
1%
Cardiac failure chronic
1%
Angina pectoris
1%
Angina unstable
1%
Ventricular tachycardia
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Sepsis
1%
Chronic kidney disease
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Basal cell carcinoma
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

CONFIDENCE 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

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,240 Previous Clinical Trials
25,331,970 Total Patients Enrolled

Media Library

Empagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05254002 — Phase 2
Chronic Kidney Disease Research Study Groups: Finerenone and Empagliflozin, Empagliflozin and Finerenone placebo, Finerenone and Empagliflozin placebo
Chronic Kidney Disease Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05254002 — Phase 2
Empagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254002 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the dangers associated with taking Empagliflozin?

"Empagliflozin falls under Phase 2 of clinical trials, meaning that while there is some data collected on the drug's safety, none exists yet regarding its efficacy. Our team has given it a score of 2."

Answered by AI

Are people still able to sign up for this trial program?

"That is correct. The listing on clinicaltrials.gov reveals that the trial is still ongoing and looking for 807 patients at 45 different sites."

Answered by AI

In how many hospitals is this trial being conducted?

"This clinical trial has locations in Toronto, Texas; Brampton, Ohio; Corpus Christi, Quebec; and 45 other sites."

Answered by AI

Who else is applying?

What site did they apply to?
Olive View - UCLA Medical Center
Global Kidney Center
Southeast Kidney Associates
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To help my kidneys. Worsening kidney disease. To advance the the treatment of CKD.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05254002.
All > Chronic Kidney Disease
~234 spots leftby Jan 2025
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