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Taking people in FrancePhase 3

Empagliflozin in adults with type 2 diabetes and severely reduced kidney function

Tests empagliflozin for reducing protein in the urine in type 2 diabetes with kidney impairment.

Key facts

Who runs it
Centre Hospitalier Universitaire De Nice
Where
Nice, FranceSee the site
Registry title
Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]
Status
Recruiting
Phase
Phase 3
People taking part
34 people, planned
Started
21 May 2026
Expected to end
1 Apr 2028
Type of study
Interventional
Record updated
5 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes and very low kidney function (eGFR between 10 and 20 ml/min/1.73m2) who lose a lot of protein in their urine.

Age
18 to 80 years
Sex
Women and men can join.
Disease stage
Type 2 diabetes with eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2, UACR > 300mg/g creatinine and UPCR > 500mg/g creatinine, and office systolic blood pressure > 110 mmHg.
Earlier treatment
Must have taken RAS (renin angiotensin system) blockers at the highest dose they can tolerate for 1 month, and must have had a stable dose of blood pressure drugs and diuretics for 1 month.
Biomarker or test result
eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2; UACR > 300mg/g creatinine; UPCR > 500mg/g creatinine.

Main reasons for not taking part

  • Past ketoacidosis while on empagliflozin or another SGLT2i drug
  • Known allergy or intolerance to empagliflozin or any of its excipients
  • Took an investigational drug in another study during the month before screening
  • No social insurance
  • Pregnant women, minors, adults under guardianship, people deprived of their liberty, or people who cannot speak French

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Type 2 diabetics
  • Age between 18 and 80 years
  • RAS (renin angiotensin system) blockade at maximal tolerated dosage for 1 month
  • eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2
  • UACR (urinary albumin creatinine ratio) > 300mg/g creatinine and UPCR (urinary protein creatinine ratio) > 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

Who cannot take part

  • Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening
  • 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
  • Known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product
  • Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo)
  • Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo)
  • Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
  • 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)

Where in France

  • Centre Hospitalier Universitaire de NiceNice, FranceTaking people

About the trial

What the trial wants to find out

1/ 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. 2/ 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 based on UPCR reduction.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]
Plain-language title
Empagliflozin in adults with type 2 diabetes and severely reduced kidney functionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
5 March 2026