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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Empagliflozin 10 MG then Placebo
  • Placebo then Empagliflozin 10 MG

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators