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 people with type 2 diabetes and chronic kidney disease

Trial purpose

The main purpose of this study is to learn how finerenone affects urinary albumin-to-creatinine ratio (uACR) over time in people with type 2 diabetes and chronic kidney disease treated in routine medical care. Participants will receive finerenone as prescribed by their usual study doctor as part of routine medical care. The study does not assign treatment. The doctor will decide the starting dose and any dose changes.
This is an observational study with 1 group only. All participants will receive finerenone if their doctor has already decided to prescribe it as part of usual care. Participants will be followed for up to 12 months after starting finerenone. Follow-up assessments are planned around Month 1, Month 3, Month 6, and Month 12, with adverse events collected up to 30 days after the last dose of finerenone.

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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