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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | empaglifozine 10mg / wash-out / matching placebo |
|
| Group 2 | Active Comparator | matching placebo / wash-out / empaglifozine 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG then Placebo | Drug | Taking Empagliflozin first |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 months |
| Urinary sodium effect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent ESNAULT, MD-PHD | Contact | 492038800 | +33 | esnault.v@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent ESNAULT, MD-PHD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nice - Hôpital Pasteur 2 | Nice | Alpes-Maritimes | 06000 | France |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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Randomized, double blind, placebo-controlled, cross over
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| Placebo then Empagliflozin 10 MG | Drug | Taking the Empagliflozin in second |
|
|
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). |
| 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. | 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). | 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)), | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 20 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |