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Completed

NCT Number: NCT05254002

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Chronic Disease Chronic Kidney Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Charleroi Hôpital civil, Lodelinsart, Hainaut, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Finerenone (BAY94-8862 ) 10 mg

Drug

oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: <60 mL/min/1.73 m2

Empagliflozin

Drug

oral administration, once daily

Empagliflozin placebo

Drug

Matching placebo to empagliflozin oral administration, once daily

Finerenone (BAY94-8862 ) 20 mg

Drug

oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2

Finerenone Placebo

Drug

Matching Placebo to Finerenone oral administration once daily

Primary outcomes

  1. Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Empagliflozin Alone

    Time frame: Baseline and Day 180

    Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline, estimated using a mixed model for repeated measures. The treatment effect is expressed as the ratio of LS means for the combination therapy group compared with empagliflozin alone. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with chronic kidney disease and type 2 diabetes.

  2. Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Finerenone Alone

    Time frame: Baseline and Day 180

    Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline in the combination therapy group compared with finerenone alone, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a measurement of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.

Secondary outcomes

  1. Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 210 Relative to Day 180

    Time frame: Up to 210 days

    Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 210 (30 days after stopping the treatment) relative to Day 180, estimated using a mixed model for repeated measures. A ratio above 1 indicates an increase in UACR at Day 210 compared with Day 180. UACR is a measurement of albuminuria, a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.

  2. Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at 30 Days After End of Treatment Relative to Baseline

    Time frame: Baseline to Day 210 (30 days after End of Treatment)

    Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) relative to baseline, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.

  3. Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)

    Time frame: At Day 180

    This outcome summarizes the number of participants whose relative change from baseline in urine albumin-to-creatinine ratio (UACR) at Day 180 met prespecified category thresholds (>30%, >40%, or >50%). Relative change was assessed based on baseline and post-baseline UACR measurements. Percentages were calculated using as denominator the number of participants with both a baseline and at least one post-baseline UACR assessment within the specified timeframe. Participants were classified independently within each category.

  4. Change From Baseline in eGFR at 30 Days

    Time frame: At Day 30

    Change from baseline to Day 30 in estimated glomerular filtration rate (eGFR) was evaluated for each treatment group. Change was calculated as the value at Day 30 minus the baseline value. Negative values indicate a decrease from baseline and positive values indicate an increase from baseline.

  5. Number of Participants With an eGFR Decline Greater Than 30% at 30 Days From Baseline

    Time frame: Up to 30 days

  6. Change in eGFR at 180 Days and 210 Days From Day 30

    Time frame: At Day 180 and Day 210

    Change in estimated glomerular filtration rate (eGFR) from Day 30 to Day 180 and Day 210 was evaluated for each treatment group. Change was calculated as the value at Day 180 or Day 210 minus the value at Day 30. Positive values indicate an increase from Day 30 and negative values indicate a decrease from Day 30.

  7. Number of Participants With AKI Events

    Time frame: 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 hours Total number of AKI events Up to 180 days

  8. Total Number of AKI Events

    Time frame: 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 hours Total number of AKI events Up to 180 days

  9. Number of Participants With Hyperkalemia Events (Moderate Hyperkalemia [5.5 <K+ ≤6.0 mmol/L], Severe Hyperkalemia [K+ >6.0 mmol/L])

    Time frame: Up to 180 days

    Moderate hyperkalemia was defined as K+ >5.5 to ≤6.0 mmol/L and severe hyperkalemia was defined as K+ >6.0 mmol/L).

  10. Change From Baseline in K+

    Time frame: At baseline, day 14 and day 180

    Serum potassium values (mmol/L) were assessed at baseline and scheduled post-baseline visits. Results are presented as observed mean potassium concentrations at each time point.

  11. Number of Participants With Symptomatic Hypotension Events

    Time frame: Up to 180 days

    Number of participants who experienced at least one symptomatic hypotension event during the study period

  12. Total Number of Symptomatic Hypotension Events

    Time frame: Up to 180 days

    Symptomatic hypotension events were assessed at all study visits and were documented as adverse events. The outcome represents the total number of symptomatic hypotension events reported during the study period.

  13. Number of Participants With Genital Mycotic Events

    Time frame: Up to 180 days

    The outcome represents the number of participants who experienced at least one genital mycotic event during the study period.

  14. Total Number of Genital Mycotic Events

    Time frame: Up to 180 days

    Occurrence of urinary tract infection events were assessed at all study visits and documented as AEs.

  15. Number of Participants With Urosepsis and Pyelonephritis Events

    Time frame: Up to 180 days

  16. Total Number of Urosepsis and Pyelonephritis Events

    Time frame: Up to 180 days

    Occurrence of urosepsis and pyelonephritis events were assessed at all study visits and documented as AEs.

  17. Number of Participants With Ketoacidosis Events

    Time frame: Up to 180 days

  18. Total Number of Ketoacidosis Events

    Time frame: Up to 180 days

    Occurrence of ketoacidosis events were assessed at all study visits and documented as AEs.

  19. Number of Participants With Necrotizing Fasciitis of the Perineum Events

    Time frame: Up to 180 days

  20. Number of Participants With Severe Hypoglycemia Events

    Time frame: Up to 180 days

    Severe hypoglycemia was defined as glucose level of <3.0 mmol/L (<54 mg/dL) is sufficiently low to indicate serious, clinically important hypoglycemia. In addition, severe hypoglycemia, as defined by the ADA denotes severe cognitive impairment requiring external assistance for recovery.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.

Acronym: CONFIDENCE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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