Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
NCT ID: NCT07074418
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
34 participants
INTERVENTIONAL
2026-04-30
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Group 1
empaglifozine 10mg / wash-out / matching placebo
Empagliflozin 10 MG then Placebo
Taking Empagliflozin first
Group 2
matching placebo / wash-out / empaglifozine 10mg
Placebo then Empagliflozin 10 MG
Taking the Empagliflozin in second
Interventions
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Empagliflozin 10 MG then Placebo
Taking Empagliflozin first
Placebo then Empagliflozin 10 MG
Taking the Empagliflozin in second
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Vincent ESNAULT, MD-PHD
Role: PRINCIPAL_INVESTIGATOR
CHU NICE
Locations
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CHU Nice - Hôpital Pasteur 2
Nice, Alpes-Maritimes, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-PP-12
Identifier Type: -
Identifier Source: org_study_id
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