2025-522119-41-00RecruitingPhase 3
Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 5 Nov 2025
- Start date
- 21 May 2026
- Lead sponsor
- Centre Hospitalier Universitaire De Nice
- Diseases
- Type 2 diabetes
- EU CT number
- 2025-522119-41-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 34
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.
Other illness
- 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
Lab values
- 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).
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Nice | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.