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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
NCT05254002 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Empagliflozin
- DRUG Finerenone (BAY94-8862 ) 10 mg
- DRUG Empagliflozin Placebo
- DRUG Finerenone (BAY94-8862 ) 20 mg
- DRUG Finerenone Placebo
Study Locations (20)
California
- Academic Medical Research Institute — Los Angeles
- Northridge Hospital — Northridge
- Olive View - UCLA Medical Center — Sylmar
- Touro University California — Vallejo
Florida
- Florida Kidney Physicians - Delray Beach Nephrology — Delray Beach
- West Orange Endocrinology & Clinical Research — Ocoee
- Innovative Research Institute — Port Charlotte
- Metabolic Research Institute, Inc. — West Palm Beach
Georgia
- Grady Memorial Hospital - Endocrinology — Atlanta
- Southeast Kidney Associates — East Point
- Velocity Clinical Research - Savannah — Savannah
Louisiana
- Nola Care Clinical Research — Metairie
- Omega Clinical Research Center — Metairie
Missouri
- Clinical Research Consultants — Kansas City
- Kansas City VA Medical Center - Endocrinology — Kansas City
Arizona
- Southwest Kidney Institute, PLC — Surprise
Connecticut
- Chase Medical Research, LLC — Waterbury
Kentucky
- Versailles Family Medicine — Versailles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,664 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05254002
The ClinicalTrials.gov registry entry for NCT05254002 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,664 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions — of which Empagliflozin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05254002 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05254002 about?
NCT05254002 is a clinical study titled "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...
What is the current status of trial NCT05254002?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,664 participants. The study started on 2022-06-23. Estimated completion is 2025-03-14.
What conditions does trial NCT05254002 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05254002?
The interventions under investigation include: Empagliflozin (DRUG), Finerenone (BAY94-8862 ) 10 mg (DRUG), Empagliflozin Placebo (DRUG), Finerenone (BAY94-8862 ) 20 mg (DRUG), Finerenone Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05254002?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05254002 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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