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
Public ClinicalTrials.gov record NCT05254002. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05254002
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,664 participants
Conditions and interventions
Conditions
Interventions
- Finerenone (BAY94-8862 ) 10 mg Drug
- Empagliflozin Drug
- Empagliflozin Placebo Drug
- Finerenone (BAY94-8862 ) 20 mg Drug
- Finerenone Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 22, 2022
- Primary completion
- Mar 13, 2025
- Completion
- Mar 16, 2025
- Last update posted
- Jul 12, 2026
2022 – 2025
United States locations
- U.S. sites
- 46
- U.S. states
- 19
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Kidney Institute, PLC - Suprise | Surprise | Arizona | 85374 | — |
| Academic Medical Research Institute | Los Angeles | California | 90022 | — |
| Dignity Health Northridge Hospital Medical Center - Nephrology | Northridge | California | 91325 | — |
| Olive View - UCLA Medical Center | Sylmar | California | 91342-1437 | — |
| Touro University California - Metabolic Research Center | Vallejo | California | 94592 | — |
| Florida Kidney Physicians - Delray Beach Nephrology | Delray Beach | Florida | 33445 | — |
| West Orange Endocrinology & Clinical Research | Ocoee | Florida | 34761 | — |
| Innovative Research Institute | Port Charlotte | Florida | 33952 | — |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | — |
| Grady Memorial Hospital - Endocrinology | Atlanta | Georgia | 30303 | — |
| Southeast Kidney Associates - East Point | East Point | Georgia | 30344 | — |
| Velocity Clinical Research - Savannah | Savannah | Georgia | 31406 | — |
| Nola Care Clinical Research | Metairie | Louisiana | 70006 | — |
| Omega Clinical Research - Metairie | Metairie | Louisiana | 70006 | — |
| South Shore Nephrology | Plymouth | Massachusetts | 02360 | — |
| Lake Michigan Nephrology | Saint Joseph | Michigan | 49085 | — |
| Oakland Medical Research | Troy | Michigan | 48085 | — |
| Clinical Research Consultants, a JCCT Company | Kansas City | Missouri | 64111 | — |
| Kansas City VA Medical Center - Endocrinology | Kansas City | Missouri | 64128 | — |
| Center for Advanced Medicine - Diabetes Center | St Louis | Missouri | 63110 | — |
| St. Louis Heart and Vascular, PC - Christian Hospital Office | St Louis | Missouri | 63136 | — |
| Somnos Clinical Research | Lincoln | Nebraska | 68510 | — |
| Healor Primary Care / CCT Research | Las Vegas | Nevada | 89102 | — |
| CCT Research - Santa Rosa Medical Centers of Nevada | Las Vegas | Nevada | 89119 | — |
| Circuit Clinical/Crystal Run | Middletown | New York | 10941 | — |
| Randolph Health Internal Medicine in Asheboro | Asheboro | North Carolina | 27203 | — |
| UNC Hospitals Outpatient Center at Eastowne - Nephrology | Chapel Hill | North Carolina | 27514 | — |
| Eastern Nephrology Associates - Greenville West | Greenville | North Carolina | 27834 | — |
| Blue Sky, MD/ Lamond Family Medicine | Hendersonville | North Carolina | 28792 | — |
| Eastern Nephrology Associates - Kinston | Kinston | North Carolina | 28504 | — |
| Velocity Clinical Research - Blue Ash | Cincinnati | Ohio | 45242 | — |
| Dunes Clinical Research LLC | Dakota Dunes | South Dakota | 57049 | — |
| DarSalud Care / LifeDOC Research | Memphis | Tennessee | 38119 | — |
| The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology | Memphis | Tennessee | 38163 | — |
| Office of Osvaldo A. Brusco, MD | Corpus Christi | Texas | 78414 | — |
| Thyroid, Endocrinology, and Diabetes - Dallas | Dallas | Texas | 75208 | — |
| DaVita Clinical Research- El Paso | El Paso | Texas | 79925 | — |
| Global Kidney Center | Houston | Texas | 77008 | — |
| Victorium Clinical Research | Houston | Texas | 77024-2593 | — |
| North Texas Kidney Disease Associates Lewisville | Lewisville | Texas | 75057 | — |
| Biopharma Informatic - McAllen, TX | McAllen | Texas | 78503 | — |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | — |
| UT Health San Antonio - Medical Arts & Research Center - Endocrinology | San Antonio | Texas | 78229 | — |
| Olympus Family Medicine | Salt Lake City | Utah | 84117 | — |
| Salem VA Medical Center - Endocrinology | Salem | Virginia | 24153 | — |
| MultiCare Rockwood Clinic Diabetes & Endocrinology Center | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 127 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05254002, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 12, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05254002 live on ClinicalTrials.gov.