Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 (EMPA[10-20])

Centre Hospitalier Universitaire de Nice

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: Chronic Kidney Diseases

Treatments: Drug: Empagliflozin 10 MG then Placebo; Drug: Placebo then Empagliflozin 10 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07074418

23-PP-12

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Group 1

Active Comparator group

Description:

empaglifozine 10mg / wash-out / matching placebo

Treatment:

Drug: Empagliflozin 10 MG then Placebo

Group 2

Active Comparator group

Description:

matching placebo / wash-out / empaglifozine 10mg

Treatment:

Drug: Placebo then Empagliflozin 10 MG