A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes
Public ClinicalTrials.gov record NCT05901831. 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, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Addition to Standard of Care, in Participants With Chronic Kidney Disease and Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: * medical problems (also called treatment-emergent adverse events (TEAEs)) * serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important * higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. 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, they will visit the study site at least 6 times. The study team will: * collect blood and urine samples * check the participants' vital signs such as blood pressure and heart rate * do a physical examination including height and weight * check the participants' heart health by using an electrocardiogram (ECG) * do pregnancy tests in women of childbearing potential
Study identification
- NCT ID
- NCT05901831
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 241 participants
Conditions and interventions
Conditions
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
- Feb 25, 2024
- Primary completion
- Aug 19, 2025
- Completion
- Sep 14, 2025
- Last update posted
- Oct 20, 2025
2024 – 2025
United States locations
- U.S. sites
- 28
- U.S. states
- 17
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Kidney Institute, PLC - Suprise | Surprise | Arizona | 85374 | — |
| Stanford Endocrinology Clinic | Stanford | California | 94305 | — |
| Touro University California - Metabolic Research Center | Vallejo | California | 94592 | — |
| UHealth Diabetes Research Center | Miami | Florida | 33136 | — |
| AdventHealth Translational Research Institute | Orlando | Florida | 32804 | — |
| Elixia Central Florida | Orlando | Florida | 32806 | — |
| Hanson Clinical Research Center, Inc. | Port Charlotte | Florida | 33952 | — |
| Jedidiah Clinical Research | Tampa | Florida | 33619 | — |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | — |
| Grady Memorial Hospital - Endocrinology | Atlanta | Georgia | 30303 | — |
| Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine | Chicago | Illinois | 60611 | — |
| UChicago Medicine Kovler Diabetes Center | Chicago | Illinois | 60637 | — |
| Preventive Intervention Center - Endocrinology | Iowa City | Iowa | 52202 | — |
| Wichita Nephrology Group Pa | Wichita | Kansas | 67214 | — |
| Diabetes & Metabolism Associates | Metairie | Louisiana | 70006 | — |
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| MU Health Care - University Hospital - Endocrinology | Columbia | Missouri | 65212 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110-1010 | — |
| UNC Endocrinology, Diabetes, and Obesity Clinical Research Unit | Chapel Hill | North Carolina | 27514 | — |
| Physicians East, P.A.- W. H. Smith - Endocrinology | Greenville | North Carolina | 27834 | — |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | — |
| Cleveland Clinic - Main Campus | Cleveland | Ohio | 44195 | — |
| OHSU Physicians Pavillion - Endocrinology | Portland | Oregon | 97239 | — |
| UT Health San Antonio - Medical Arts & Research Center - Endocrinology | San Antonio | Texas | 78229 | — |
| Consano Clinical Research, LLC. | San Antonio | Texas | 79231 | — |
| EVMS Strelitz Diabetes Center | Norfolk | Virginia | 23510 | — |
| Providence Medical Research Center | Spokane Valley | Washington | 99204 | — |
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 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05901831, 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 Oct 20, 2025 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05901831 live on ClinicalTrials.gov.