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NCT05254002 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,664
- Enrollment target
- 20
- Study locations
NCT05254002 is a Phase 2 study of Type 2 Diabetes Mellitus and Chronic Kidney Disease that has completed, run by Bayer. The registered enrollment target is 1,664 participants, below the 2,735-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT05254002, a Phase 2 study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,664 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 1,664 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,735-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (39% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
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.
NCT05254002 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.
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.
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).
Who is sponsoring clinical trial NCT05254002?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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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