Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2

Korábbi kezelés

• participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening,

Más betegség

• 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,
• known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product,

Egyéb

• 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).

• 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.
• for women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed.