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
- Not Yet Recruiting
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Conditions
- Chronic Kidney Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin 10 MG then Placebo — DRUGTaking Empagliflozin first
- Placebo then Empagliflozin 10 MG — DRUGTaking the Empagliflozin in second
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
- Start date
- Apr 30, 2026
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 34 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Group 1empaglifozine 10mg / wash-out / matching placebo
- Active Comparator: Group 2matching placebo / wash-out / empaglifozine 10mg
Primary Outcome Measure
Anti-proteinuric effect [ Time Frame: 20 months ]
Central Contacts
- Vincent ESNAULT, MD-PHD492038800
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