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NCT05901831 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Type 1 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
- 20
- Study locations
NCT05901831 is a Phase 3 study of Type 1 Diabetes Mellitus and Chronic Kidney Disease that has completed, run by Bayer. The registered enrollment target is 241 participants, above the 138-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (75% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT05901831, a Phase 3 study of Type 1 Diabetes Mellitus and Chronic Kidney Disease, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Finerenone
Study Locations (20)
Florida
- UHealth Diabetes Research Center - Miami
- AdventHealth Translational Research Institute - Orlando
- Elixia Central Florida - Orlando
- Hanson Clinical Research Center, Inc. - Port Charlotte
- Jedidiah Clinical Research - Tampa
- Metabolic Research Institute, Inc. - West Palm Beach
California
- Stanford Endocrinology Clinic - Stanford
- Touro University California - Metabolic Research Center - Vallejo
Illinois
- Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine - Chicago
- UChicago Medicine Kovler Diabetes Center - Chicago
Missouri
- MU Health Care - University Hospital - Endocrinology - Columbia
- Washington University School of Medicine in St. Louis - St Louis
Arizona
- Southwest Kidney Institute, PLC - Suprise - Surprise
Georgia
- Grady Memorial Hospital - Endocrinology - Atlanta
Iowa
- Preventive Intervention Center - Endocrinology - Iowa City
Kansas
- Wichita Nephrology Group Pa - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2024-02-26 |
| Est. Completion | 2025-09-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05901831
The ClinicalTrials.gov registry entry for NCT05901831 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 138-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (75% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05901831 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05901831 about?
NCT05901831 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05901831?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2024-02-26. Estimated completion is 2025-09-15.
What conditions does trial NCT05901831 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, Chronic Kidney Disease.
What interventions are being tested in trial NCT05901831?
The interventions under investigation include: Placebo (OTHER), Finerenone (DRUG).
Who is sponsoring clinical trial NCT05901831?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05901831 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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