Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]
Key facts
- Where
- Nice, FranciaországSee the site
- Phase
- 3. fázis
Where in Franciaország
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire De Nice
- Trial code
- EU 2025-522119-41-00
- Record updated
- 2026. március 5.
- Original description
1/ 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. 2/ 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 based on UPCR reduction.Read full original descriptionShow less
1/ 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. 2/ 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 based on UPCR reduction.
Inclusion: Type 2 diabetics; Age between 18 and 80 years; RAS (renin angiotensin system) blockade at maximal tolerated dosage for 1 month; eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2; UACR (urinary albumin creatinine ratio) > 300mg/g creatinine and UPCR (urinary protein creatinine ratio) > 500mg/g creatinine; Office systolic blood pressure > 110 mmHg; Stable dosage of antihypertensive drugs and diuretics for 1 month; For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used For more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed.
Exclusion: Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening; 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; Known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product; Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo); Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo); Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements; No social insurance; Unwilling to give informed consent, vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French).