An observational study in Type 2 Diabetes and Chronic Kidney Disease (CKD) Stages G2 to G3b, sponsored by Bayer. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Bayer · Observational
The main purpose of this study is to learn how treatment with finerenone affects the urinary albumin-to-creatinine ratio (uACR), a marker of kidney health, over time in adults with type 2 diabetes and chronic kidney disease who are receiving care in primary care clinics as part of their usual medical care. The study will help researchers better understand how finerenone is used and how people respond to treatment in everyday primary care settings.
This is an observational study, which means the study does not decide or assign treatment. Participants will receive finerenone only if their primary care doctor has already decided to prescribe it as part of routine medical care. The doctor will determine the starting dose and make any dose changes based on the participant's individual needs.
All participants will be enrolled in a single study group and followed for up to 12 months after starting finerenone. Information collected during routine primary care visits may include kidney health measurements, laboratory test results, other medications, healthcare use, and any side effects experienced during treatment. Follow-up assessments are planned around Month 1, Month 3, Month 6, and Month 12. Information about adverse events will be collected until 30 days after the participant's last dose of finerenone. The study will not require additional treatment decisions beyond routine care and aims to understand how finerenone performs in real-world primary care practice.
Adult patients aged ≥18 years with T2D and CKD, of both sexes, treated in IMSS primary care units, who start treatment with finerenone as part of routine clinical practice.
Exclusion Criteria:
Patients initiate finerenone according to routine clinical practice.
Drug: Finerenone
Follow clinical practice/administration.
Evolution of the urinary albumin-to-creatinine ratio (uACR)
Assessed by change from baseline at 1, 3, 6 and 12 months after initiation of finerenone treatment.
Time frame: Baseline and at months 1, 3, 6 and 12
Proportion of patients achieving a clinically relevant reduction in uACR
Defined as a relative decrease of at least 30% from baseline.
Time frame: Baseline and at months 1, 3, 6 and 12
Magnitude of the relative change in uACR
Categorization of patients into response ranges \<30%, 30% to \<50%, and \>=50% reduction from baseline.
Time frame: Baseline and at months 1, 3, 6 and 12
Adherence and persistence to finerenone treatment
Adherence and persistence during follow-up under routine clinical practice conditions.
Time frame: 12 months
Safety profile of finerenone
Occurrence of potentially treatment-related adverse events, serum potassium abnormalities, early eGFR changes, and related clinical actions.
Time frame: Up to 12 months
Use of health resources
Consultations and laboratory studies according to information available in medical records.
Time frame: Up to 12 months
Plan to share: No — Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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