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Completed Phase 2 Interventional Results available

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 ID: NCT05254002

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.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:04 PM EDT

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
Lead sponsor
Bayer
Industry
Enrollment
1,664 participants

Conditions and interventions

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.

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