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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2027-12-31

Brief Summary

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The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure. The investigators therefore hypothesize that SGLT2i should still exert a significant natriuretic effect in patients with eGFR below 20 ml/min/1.73m2, and therefore should still decrease proteinuria with a potential renal protective effect.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double blind, placebo-controlled, cross over
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

empaglifozine 10mg / wash-out / matching placebo

Group Type ACTIVE_COMPARATOR

Empagliflozin 10 MG then Placebo

Intervention Type DRUG

Taking Empagliflozin first

Group 2

matching placebo / wash-out / empaglifozine 10mg

Group Type ACTIVE_COMPARATOR

Placebo then Empagliflozin 10 MG

Intervention Type DRUG

Taking the Empagliflozin in second

Interventions

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Empagliflozin 10 MG then Placebo

Taking Empagliflozin first

Intervention Type DRUG

Placebo then Empagliflozin 10 MG

Taking the Empagliflozin in second

Intervention Type DRUG

Other Intervention Names

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EMPAGLIFLOZIN or iSGLT2 EMPAGLIFLOZIN or iSGLT2

Eligibility Criteria

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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.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Central Contacts

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Vincent ESNAULT, MD-PHD

Role: CONTACT

492038800 ext. +33

Facility Contacts

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Vincent ESNAULT, MD-PHD

Role: primary

492038800 ext. +33

Other Identifiers

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23-PP-12

Identifier Type: -

Identifier Source: org_study_id

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