A Phase 3 interventional study of Finerenone and Placebo in Chronic Kidney Disease and Type 1 Diabetes Mellitus, sponsored by Bayer. Completed at 80 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-21.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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:
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:
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's enrollment of 241 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with Type 1 diabetes (T1D), i.e. T1D continuously treated with insulin, started within one year from diagnosis.
If the onset was after age 35, documentation of the presence of one or more of the following:
HbA1c at Screening \<10% (central assessment).
Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment):
Exclusion Criteria:
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.
Drug: Finerenone
Participants will take Finerenone matching placebo for 6 months.
Other: Placebo
Dose A, Dose B, oral
Oral
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
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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