Studies how finerenone is used in people with kidney disease and type 2 diabetes

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial looks at adults with chronic kidney disease (stages 2-4) and type 2 diabetes who have started finerenone as part of their usual care. It only uses existing health records.

Age

18 years or older

Sex

All sexes can join

Disease stage

Type 2 diabetes and chronic kidney disease stages 2-4 (or stage not stated), shown by a diagnosis code or by repeated urine (UACR ≥ 30 mg/g) or kidney (eGFR ≥ 15 and < 60 mL/min/1.73 m2) test results

Earlier treatment

No recorded finerenone prescription in the 12 months before the index date

Biomarker or test result

Two UACR results of 30 mg/g or more, or two eGFR results of 15 or more and below 60 mL/min/1.73 m2, each pair at least 90 days and not more than 540 days apart (an alternative to a CKD diagnosis code)

Main reasons for not taking part

• Kidney failure (two eGFR results below 15 mL/min/1.73 m2, or a kidney failure or CKD stage 5 diagnosis code)
• Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period)
• Kidney transplant
• Less than 12 months of continuous enrolment in the database

The registry criteria, word for word

What the trial wants to find out

This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.

The group in the trial

• Adult patients with CKD and T2D who initiate finerenone

  The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Asia and in the United States.

  Treatment: Finerenone (BAY 94-8862)