A Phase 4 interventional study of Empagliflozin 10 MG then Placebo and Placebo then Empagliflozin 10 MG in Chronic Kidney Diseases, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 4, Interventional, and Treatment
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.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 34 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
empaglifozine 10mg / wash-out / matching placebo
Drug: Empagliflozin 10 MG then Placebo
matching placebo / wash-out / empaglifozine 10mg
Drug: Placebo then Empagliflozin 10 MG
Taking Empagliflozin first
Also known as: EMPAGLIFLOZIN or iSGLT2
Taking the Empagliflozin in second
Also known as: EMPAGLIFLOZIN or iSGLT2
Anti-proteinuric effect
Changes in mean UACR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo). To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, SGLT2i exerts a clinically significant anti-proteinuric effect.
Time frame: 20 months
Body weight effect
Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo. To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin acutely decreases body weight.
Time frame: 20 months
Urinary sodium effect
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: increases urinary sodium excretion. Changes in mean UPCR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
Urinary volume effect
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: increases urinary volume. Changes in mean 24-hour urinary.
Time frame: 20 months
Blood pressure effect
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: decreases ambulatory blood pressure. Changes in mean ambulatory systolic blood pressure between 3 days running baseline and 3 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
eGFR effect by good profile
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has a good safety profile (no acute kidney injury or hyperkalaemia \> 5.5 mmol/L or acidosis (serum bicarbonate \<23 mmol/L)),
Time frame: 20 months
eGFR effect by levels
Changes in eGFR levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
eGFR effect by serum potassium
Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
eGFR effect by serum bicarbonate
Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
eGFR effect by albuminuria
Changes in mean 24-hour albuminuria between 3 days running urinary collections at baseline and after starting each treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
Effect on HbA1c
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has no significant effect on HbA1c. Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
Magnitude of eGFR by TEAEs
Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of treatment emergent adverse events (TEAEs).
Time frame: 20 months
Magnitude of eGFR by SAEs
Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of serious adverse events (SAEs).
Time frame: 20 months
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Centre Hospitalier Universitaire de Nice