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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Centre Hospitalier Universitaire de Nice • ClinicalTrials.gov ID: NCT07074418

Registry updated: 2026-09-10
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Description

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.

Interventions

  • Empagliflozin 10 MG then Placebo (Drug)
    Taking Empagliflozin first
  • Placebo then Empagliflozin 10 MG (Drug)
    Taking the Empagliflozin in second

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. * 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. 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).

Conditions

Chronic Kidney Diseases

Locations

  • CHU Nice - Hôpital Pasteur 2 — Nice, Alpes-Maritimes, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record