Empagliflozin in very low eGFR with chronic kidney disease
Official title: Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 - EMPA [10-20]
Run by Centre Hospitalier Universitaire de Nice · NCT07074418 · Data updated 2026-11-12
This study tests whether empagliflozin can help people with advanced kidney disease and type 2 diabetes who have very low kidney function by reducing kidney protein leakage and potentially protecting kidney function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes-Maritimes) |
| Status | Recruiting |
| Started | August 25, 2026 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07074418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with type 2 diabetes, eGFR 10–20, high urine protein, on maximal tolerated RAS blockade, and stable antihypertensive therapy.
✕Probably not a fit
Patients without significant proteinuria reduction or with safety concerns may not benefit from the treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 trial examines the effect of empagliflozin 10 mg compared to placebo in adults with chronic kidney disease and an eGFR between 10 and 20 ml/min/1.73 m2. Participants continue standard diabetes and blood pressure therapies, with careful monitoring of safety and kidney-related outcomes. The design includes a crossover-like sequence where patients receive empagliflozin then placebo, followed by placebo then empagliflozin, to observe changes in proteinuria and related renal markers. Eligibility requires type 2 diabetes, controlled blood pressure, stable medications, and specific proteinuria levels, while excluding individuals with recent ketoacidosis or recent IMP exposure.
Why it matters
Potential benefit: If successful, participants could see reduced proteinuria and potential kidney protection with empagliflozin in very low eGFR.
How similar studies have gone: Prior studies of SGLT2 inhibitors in advanced kidney disease have shown potential proteinuric and renal benefits in selected populations, but results at very low eGFR are less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * type 2 diabetics, * age between 18 and 80 years, * RAS blockade at maximal tolerated dosage for 1 month, * eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2, * UACR \> 300mg/g creatinine and UPCR \> 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 Criteria: * 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, * 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).
Where it's running
-
CHU Nice - Hôpital Pasteur 2
Nice, Alpes-Maritimes, France Recruiting
Study contacts
- Principal investigator: Guillaume FAVRE, MD-PHD — Centre Hospitalier Universitaire de Nice
- Study coordinator: Guillaume FAVRE, MD-PHD
- Email: favre.g@chu-nice.fr
- Phone: 492038428
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.