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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05901831

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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:02 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, 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
Lead sponsor
Bayer
Industry
Enrollment
241 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
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

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05901831 live on ClinicalTrials.gov.

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