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Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]
EU CTIS ID: 2025-522119-41-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Any medical condition that, in the opinion of the investigator, makes the participant not suitable for inclusion
- Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
- History of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs
- Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.
- Known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product
- 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.
See the full eligibility criteria
- 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.
- Any medical condition that, in the opinion of the investigator, makes the participant not suitable for inclusion
- Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
- History of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs
- Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.
- Known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product
- 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).
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.