A Study to Learn More About How Well Finerenone Works in Real-World in People With Type 2 Diabetes and Chronic Kidney Disease in Primary Care (IMSS= Instituto Mexicano Del Seguro Social)

NCT07841015 | Not Yet Recruiting

• 1 other identifier: 23223
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Chronic Kidney Disease (CKD) Stages G2 to G3b

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at months 1, 3, 6 and 12

Secondary Outcomes (5)

• Proportion of patients achieving a clinically relevant reduction in uACR

  Baseline and at months 1, 3, 6 and 12

• Magnitude of the relative change in uACR

  Baseline and at months 1, 3, 6 and 12

• Adherence and persistence to finerenone treatment

  12 months

• Safety profile of finerenone

  Up to 12 months

• Use of health resources

  Up to 12 months

Study Arms (1)

Finerenone

Patients initiate finerenone according to routine clinical practice.

Drug: Finerenone

Interventions

Finerenone DRUG

Follow clinical practice/administration.

Finerenone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult participant - all genders (\>=18 years old).
• Documented diagnosis of Type 2 diabetes (T2D), according to clinical criteria used in routine clinical practice.
• Documented diagnosis of Chronic Kidney Disease (CKD) in stages G2 to G3b, defined by an estimated glomerular filtration rate (Estimated Glomerular Filtration Rate \[eGFR\] \>=30 and \<90 mL/min/1.73 m\^2 according to the information available in the clinical record).
• Signed informed consent.
• Prescription of finerenone within the authorized indications and in accordance with the prescribing information in force in the local market.
• No contraindications to the use of finerenone, in accordance with local marketing authorization and prescribing information in force.

You may not qualify if:

• Concomitant participation in an interventional clinical study involving interventions outside of routine clinical practice at any time during the follow-up period of the present study.
• Contra-indications according to the local label.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

finerenone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

0018888422937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 25, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)