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

Sponsor
Centre Hospitalier Universitaire de Nice
Study ID
NCT07074418
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 20, 2025
Start date
Aug 25, 2026
Status verified
Sep 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1
    empaglifozine 10mg / wash-out / matching placebo
  • Active Comparator: Group 2
    matching placebo / wash-out / empaglifozine 10mg

Primary Outcome Measure

Anti-proteinuric effect [ Time Frame: 20 months ]

Central Contacts

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