Can a diabetes drug protect kidneys when they're barely working?
NCT ID NCT07074418
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This study tests whether empagliflozin, a diabetes medicine, can reduce protein leakage in urine and help protect the kidneys in people with very advanced chronic kidney disease (eGFR between 10 and 20). About 34 adults with type 2 diabetes will take either empagliflozin or a placebo for 6 weeks each. The goal is to see if the drug still works to lower protein in urine even when kidney function is severely reduced.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Nice - Hôpital Pasteur 2
RECRUITINGNice, Alpes-Maritimes, 06000, France
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