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:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT07074418
Eligibility Criteria:
Inclusion Criteria:
* type 2 diabetics,
* age between 18 and 80 years,
* RAS blockade at maximal tolerated dosage for 1 month,
* eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2,
* UACR \> 300mg/g creatinine and UPCR \> 500mg/g creatinine,
* office systolic blood pressure \> 110 mmHg,
* stable dosage of antihypertensive drugs and diuretics for 1 month.
Exclusion Criteria:
* any medical condition that, in the opinion of the investigator makes the participant not suitable for inclusion,
* history of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs,
* participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening,
* known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product,
* judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements,
* no social insurance,
* unwilling to give informed consent, vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07074418
Study Brief:
Protocol Section:
NCT07074418