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 statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBayer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 m² 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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Finerenone

    Drug

    Follow clinical practice/administration.

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Finerenone1 intervention

Trial outcomes

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.

Time frame
Baseline and at months 1, 3, 6 and 12

Secondary outcomes

1

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
2

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
3

Adherence and persistence to finerenone treatment

Adherence and persistence during follow-up under routine clinical practice conditions.

Time frame
12 months
4

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Many locations Status unavailable Multiple LocationsMexicoMexico

Sponsors and contacts

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