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)
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| ClinicalTrials.gov Identifier: NCT05254002 |
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Recruitment Status :
Recruiting
First Posted : February 24, 2022
Last Update Posted : May 7, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus Chronic Kidney Disease | Drug: Finerenone (BAY94-8862 ) 10 mg Drug: Empagliflozin Drug: Empagliflozin Placebo Drug: Finerenone (BAY94-8862 ) 20 mg Drug: Finerenone Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 807 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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. |
| Actual Study Start Date : | June 23, 2022 |
| Estimated Primary Completion Date : | January 31, 2025 |
| Estimated Study Completion Date : | February 28, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Finerenone and Empagliflozin
Participants will take Finerenone (10 or 20 mg once daily [OD]) and Empagliflozin (10 mg OD) for up to 180 days.
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Drug: Finerenone (BAY94-8862 ) 10 mg
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: <60 mL/min/1.73 m2 Drug: Empagliflozin oral administration, once daily Drug: Finerenone (BAY94-8862 ) 20 mg oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2 |
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Experimental: Finerenone and Empagliflozin placebo
Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
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Drug: Finerenone (BAY94-8862 ) 10 mg
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: <60 mL/min/1.73 m2 Drug: Empagliflozin Placebo Matching placebo to empagliflozin oral administration, once daily Drug: Finerenone (BAY94-8862 ) 20 mg oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2 |
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Experimental: Empagliflozin and Finerenone placebo
Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.
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Drug: Empagliflozin
oral administration, once daily Drug: Finerenone Placebo Matching Placebo to Finerenone oral administration once daily |
- Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone [ Time Frame: 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 [ Time Frame: Up to 180 days ]
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone [ Time Frame: Upto 180 days ]
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone [ Time Frame: 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) [ Time Frame: Up to 210 days ]
- Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1) [ Time Frame: Up to 210 days ]
- Relative change in UACR category (>30%, >40%, >50%) at 180 days [ Time Frame: Up to 180 days ]
- Ratio of change from baseline in eGFR at 30 days [ Time Frame: Up to 30 days ]estimated glomerular filtration rate (eGRF)
- eGFR decline greater than 30% at 30 days from baseline [ Time Frame: Up to 30 days ]
- Ratio of change in eGFR at 180 days and 210 days from Day 30 [ Time Frame: Up to 210 days ]
- Proportion of participants with of acute kidney injury (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 [ Time Frame: Up to 180 days ]
- Proportion 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 ]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]) [ Time Frame: Up to 180 days ]
- Change from baseline in K+ [ Time Frame: Up to 180 days ]
- Proportion of participants with severe hypoglycemia events [ Time Frame: 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 [ Time Frame: Up to 180 days ]
- Proportion of participants with symptomatic hypotension events [ Time Frame: Up to 180 days ]
- Total number of symptomatic hypotension events [ Time Frame: Up to 180 days ]
- Proportion of participants with genital mycotic events [ Time Frame: Up to 180 days ]
- Total number of genital mycotic events [ Time Frame: Up to 180 days ]
- Proportion of participants with ketoacidosis events [ Time Frame: Up to 180 days ]
- Total number of ketoacidosis events [ Time Frame: Up to 180 days ]
- Proportion of participants with necrotizing fasciitis of the perineum events [ Time Frame: Up to 180 days ]
- Total number of necrotizing fasciitis of the perineum events [ Time Frame: Up to 180 days ]
- Proportion of participants with urosepsis and pyelonephritis events [ Time Frame: Up to 180 days ]
- Total number of urosepsis and pyelonephritis events [ Time Frame: Up to 180 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05254002
| Contact: Bayer Clinical Trials Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT05254002 |
| Other Study ID Numbers: |
21839 2023-506981-30-00 ( Registry Identifier: CTIS ) 2021-003037-11 ( EudraCT Number ) |
| First Posted: | February 24, 2022 Key Record Dates |
| Last Update Posted: | May 7, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Kidney Diseases Renal Insufficiency, Chronic Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes Empagliflozin Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |