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NCT Number: NCT07074418

Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, 06000, France

Location contact

Vincent ESNAULT, MD-PHD

CONTACT

[email protected]

492038800 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Empagliflozin 10 MG then Placebo

Drug

Taking Empagliflozin first

Other names: EMPAGLIFLOZIN or iSGLT2

Placebo then Empagliflozin 10 MG

Drug

Taking the Empagliflozin in second

Other names: EMPAGLIFLOZIN or iSGLT2

Primary outcomes

  1. Anti-proteinuric effect

    Time frame: 20 months

    Changes in mean UACR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).

    To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, SGLT2i exerts a clinically significant anti-proteinuric effect.

Secondary outcomes

  1. Body weight effect

    Time frame: 20 months

    Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo.

    To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin acutely decreases body weight.

  2. Urinary sodium effect

    Time frame: 20 months

    To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin:

    increases urinary sodium excretion. Changes in mean UPCR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).

  3. Urinary volume effect

    Time frame: 20 months

    To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin:

    increases urinary volume. Changes in mean 24-hour urinary.

  4. Blood pressure effect

    Time frame: 20 months

    To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: decreases ambulatory blood pressure.

    Changes in mean ambulatory systolic blood pressure between 3 days running baseline and 3 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).

  5. eGFR effect by good profile

    Time frame: 20 months

    To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has a good safety profile (no acute kidney injury or hyperkalaemia > 5.5 mmol/L or acidosis (serum bicarbonate <23 mmol/L)),

  6. eGFR effect by levels

    Time frame: 20 months

    Changes in eGFR levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).

  7. eGFR effect by serum potassium

    Time frame: 20 months

    Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).

  8. eGFR effect by serum bicarbonate

    Time frame: 20 months

    Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).

  9. eGFR effect by albuminuria

    Time frame: 20 months

    Changes in mean 24-hour albuminuria between 3 days running urinary collections at baseline and after starting each treatment period (empagliflozin 10 mg/d and matching placebo).

  10. Effect on HbA1c

    Time frame: 20 months

    To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has no significant effect on HbA1c.

    Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).

  11. Magnitude of eGFR by TEAEs

    Time frame: 20 months

    Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of treatment emergent adverse events (TEAEs).

  12. Magnitude of eGFR by SAEs

    Time frame: 20 months

    Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of serious adverse events (SAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent ESNAULT, MD-PHD

CONTACT

[email protected]

492038800 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

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

Acronym: EMPA[10-20]

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 20, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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