Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT06608212
Eligibility Criteria:
Inclusion criteria on or before Time 0 (Time 0 = finerenone initiation date) :
* Active registration or continuous enrolment for at least 365 days in the data source before Time 0 (days \[-365, 0\])
* No recorded use of finerenone before Time 0 (days \[-all available, 0\])
* Aged 18 years or older on Time 0
* Diagnosis of T2D at any time on or before Time 0 (days \[-all available, 0\])
* Having a diagnosis code indicating CKD stage 1, 2, 3, 4, or stage unspecified on or before Time 0 (days \[-all available, 0\])
Exclusion criteria on or before Time 0:
* Finerenone users who are hospitalized or admitted for an emergency department visit on Time 0
* Type 1 diabetes (T1D) at any time on or before Time
* Evidence of end-stage kidney disease (ESKD) at any time on or before Time 0
* A diagnosis of kidney cancer at any time on or before Time 0
* A diagnosis of adrenal insufficiency at any time on or before Time 0
* Evidence of hepatic impairment at any time on or before Time 0
* An eGFR measurement \< 25 mL/min/1.73 m2 on or in the 90 days before Time 0
* Evidence of recent increased serum potassium or hyperkalaemia
* Use of a strong CYP3A4 inhibitor on or in the 183 days before Time 0
* Evidence of pregnancy measured on or in the 40 weeks before Time 0
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06608212
Study Brief:
Protocol Section:
NCT06608212