Not Yet Recruiting

Type 2 diabetes, Chronic kidney disease (CKD) stages G2 to G3b

Bayer Identifier:

23223

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

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)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A (No Limit)

Inclusion Criteria

• 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).
• Baseline urinary albumin-to-creatinine ratio (uACR) value >=30 mg/g, documented at the time of inclusion in the study.
• Decision to initiate treatment with finerenone made by the physician as part of his or her routine clinical practice and independently of the patient's inclusion in the study.
• Baseline serum potassium <5.0 mmol/L, determined prior to or at the time of inclusion in the study.
• 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.

Exclusion Criteria

• 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.

Trial summary

Enrollment Goal

800

Trial Dates

September 2026 - December 2027

Phase

Phase IV

Could I Receive a placebo

Products

Finerenone, BAY 948862

Accepts Healthy Volunteer

Primary Outcome

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

Secondary Outcome

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

Trial design

FINE-IMSS-MX trial: RWE treatment with finerenone in Mexico

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

Open Label

Assignment

N/A

Trial Arms

N/A

Additional Information

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