Observational study on the use of finerenone for chronic kidney disease and type 2 diabetes

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 observational study aims to gather data from participants in Japan and the United States who have chronic kidney disease (CKD) and type 2 diabetes (T2D) and are already receiving finerenone as part of their standard medical care. The study will monitor the safety and effectiveness of finerenone in real-world conditions without imposing any specific interventions. CKD often develops as a complication of T2D, and finerenone may help mitigate kidney damage by blocking mineralocorticoid receptors. Participants will be tracked over time to assess outcomes related to their kidney health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
* No recorded prescription for finerenone in the 12 months prior to the index date
* Age of 18 years or older as of the index date
* Evidence of T2D at any point before (and including) the index date.
* CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:

  * A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified
  * two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days
  * two different eGFR test results ≥ 15 mL/min/1.73 m2 AND \< 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days

Exclusion Criteria:

\- Kidney failure defined as follows:

* Two different eGFR test results \< 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
* Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
* A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant

Where it's running

• Bayer
  Berlin, Germany Recruiting
• Many Locations
  Many Locations, New Jersey, United States Completed
• Many Locations
  Many Locations, Japan Completed
• Many Locations
  Many Locations, Taiwan Completed

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  This observational study tests how finerenone affects a kidney-risk score in adults with CKD linked to type 2 diabetes who are already taking finerenone in routine care in Spain.

  Recruiting Bayer · Many Locations · NCT07554469

• Evaluating the effects of finerenone on kidney function in patients with Type 2 diabetes and chronic kidney disease

  This study is testing if adding a new kidney medication called finerenone can help people with Type 2 diabetes and chronic kidney disease improve their kidney function over 48 weeks.

  Recruiting Second Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT06838416

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  This study is trying to find out how nutrition and the environment affect the health of older people living in Nanshan to help prevent diseases like high blood pressure and diabetes.

  Recruiting Sun Yat-sen University · Shenzhen, Guangdong and 1 other locations · NCT03569735

• Observational look at how Kremezin works in adults with advanced chronic kidney disease

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• Acupuncture plus vitamin B12 for diabetic heart nerve damage

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  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07907536

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.