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

Conditions

• Chronic Kidney Disease
• Type 1 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Finerenone — DRUG
  Dose A, Dose B, oral
• Placebo — OTHER
  Oral

Study Details

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

Key Dates

Start date

Feb 26, 2024

Status verified

Oct 2025

Primary completion

Aug 20, 2025

Completion

Sep 15, 2025

Study Design

Enrollment

241 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Finerenone arm
  Participants with eGFR ≥25 to \<60 mL/min/1.73 m\^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m\^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.
• Placebo Comparator: Placebo arm
  Participants will take Finerenone matching placebo for 6 months.

Primary Outcome Measure

Change in Urinary albumin-to-creatinine ratio (UACR) [ Time Frame: From baseline up to 6 months ]

Locations (28)

Related coverage on Hipa.ai

• Finerenone Phase 3 Trial for CKD and Type 1 Diabetes Completes
  Finerenone · Aug 20, 2025 · ClinicalTrials.gov

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