Finerenone in adults with CKD and type 2 diabetes in Spain: real-world changes in kidney risk score

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational study using data from adults with CKD due to type 2 diabetes who are being treated with finerenone in routine practice in Spain. The goal is to analyze changes in a CKD risk score, such as Klinrisk, over time as patients continue finerenone therapy. Researchers will collect information from standard clinical tests like eGFR and UACR and other routine lab results to understand how the risk of disease progression evolves in real-world settings. The study does not assign treatment but observes outcomes in patients already prescribed finerenone according to local practice. Results may help clarify how finerenone-related risk profiles change in routine care outside of randomized trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who sign the written informed consent to participate in the study.
* Men or women aged ≥18 years.
* Patients with CKD associated with type 2 diabetes and albuminuria (UACR \>30 mg/g).
* Patients initiated on finerenone in routine clinical practice, according to the Summary of Product Characteristics (SmPC), within the 2 months prior to inclusion.

Exclusion Criteria:

* eGFR \< 25 mL/min/1.73 m².
* Severe hepatic impairment.
* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms.
* Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
* Uncontrolled arterial hypertension (mean sitting systolic blood pressure \[SBP\] ≥160 mmHg or diastolic blood pressure \[DBP\] ≥100 mmHg at inclusion).
* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or a potassium-sparing diuretic that has not been discontinued at least 4 weeks prior to inclusion.

Where it's running

• Many locations
  Many Locations, Spain Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.