Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Decision date (initial)

2026-03-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy

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.

Secondary objectives 4

1. To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin acutely decreases body weight.
2. To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: a. increases urinary sodium excretion and urinary volume, b. decreases ambulatory blood pressure, c. increases serum potassium levels and serum bicarbonate levels, d. has a good safety profile (no acute kidney injury or hyperkaliemia > 5.5 mmol/L or acidosis (serum bicarbonate <23 mmol/L)), e. has no significant effect on HbA1c.
3. Comparison of the magnitude of eGFR decrease following empagliflozin or placebo treatments.
4. To show that mean 24-hour albuminuria decreases in the empagliflozine group compare to placebo.

Conditions and MedDRA coding

Patients with renal impairment and type 2 diabetes.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Type 2 diabetics.
2. Age between 18 and 80 years.
3. RAS (renin angiotensin system) blockade at maximal tolerated dosage for 1 month.
4. eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2
5. UACR (urinary albumin creatinine ratio) > 300mg/g creatinine and UPCR (urinary protein creatinine ratio) > 500mg/g creatinine
6. Office systolic blood pressure > 110 mmHg
7. Stable dosage of antihypertensive drugs and diuretics for 1 month
8. 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.

Exclusion criteria 10

1. Any medical condition that, in the opinion of the investigator, makes the participant not suitable for inclusion
2. History of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs
3. Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.
4. Known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product
5. 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.
6. No social insurance
7. 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).
8. Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
9. Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
10. Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1/ 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). 2/ 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).

Secondary endpoints 7

1. 1/Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
2. 2/a) Changes in mean 24-hour urinary sodium excretion and urinary volume between 3 days running urinary collections at baseline and 3 days after starting each treatment period (empagliflozin 10 mg/d and matching placebo). The measures will be the mean of each 3 days period.
3. 2/b) 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),
4. 2/c) Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo), changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
5. 2/d) Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), (no acute kidney injury or hyperkalaemia > 5.5 mmol/L or acidosis (serum bicarbonate <23 mmol/L))
6. 3/ Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
7. 4/ To show that mean 24-hour albuminuria decreases in the empagliflozine group compare to placebo group in the 3 days following the beginning of the treatment compare to the 3 days before. The measures will be the mean of each 3 days period

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

30 Voie Romaine

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Pr Guillaume FAVRE

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Céline CELLIER-COËLLE

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications