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NCT07074418
Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
Conditions: Chronic Kidney Diseases
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 34
Sponsor: Centre Hospitalier Universitaire de Nice
Location: CHU Nice - Hôpital Pasteur 2 Nice Alpes-Maritimes
Summary
The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure. The investigators therefore hypothesize that SGLT2i should still exert a significant natriuretic effect in patients with eGFR below 20 ml/min/1.73m2, and therefore should still decrease proteinuria with a potential renal protective effect.
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).
Source: ClinicalTrials.gov (NCT07074418). StuddyBuddy aggregates publicly available trial information.