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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
241
Dose A, Dose B, oral
Oral
Southwest Kidney Institute, PLC - Suprise
Surprise, Arizona, United States
Stanford Endocrinology Clinic
Stanford, California, United States
Touro University California - Metabolic Research Center
Vallejo, California, United States
UHealth Diabetes Research Center
Miami, Florida, United States
AdventHealth Translational Research Institute
Orlando, Florida, United States
Change in Urinary albumin-to-creatinine ratio (UACR)
UACR will be assessed by the Central laboratory.
Time frame: From baseline up to 6 months
Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
Time frame: From baseline up to 7 months
Number of participants with Hyperkalaemia
Hyperkalemia will be an adverse events of special interest (AESI).
Time frame: From baseline up to 7 months
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Elixia Central Florida
Orlando, Florida, United States
Hanson Clinical Research Center, Inc.
Port Charlotte, Florida, United States
Jedidiah Clinical Research
Tampa, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Grady Memorial Hospital - Endocrinology
Atlanta, Georgia, United States
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