Chronic Kidney DiseasesPhase 4EMPA[10-20]NCT07074418
Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
A Phase 4 study of Chronic Kidney Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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 join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nice - Hôpital Pasteur 2
Nice, Alpes-Maritimes, 06000
Guillaume FAVRE, MD-PHD, 492038428 ext. +33, favre.g@chu-nice.fr
About this study
Official title: Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 - EMPA [10-20]
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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Empagliflozin 10 MG then Placebo, Placebo then Empagliflozin 10 MG
- Keywords
- Chronic Kidney Disease, Nephrology, eGFR
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MG then PlaceboDrug
Also called EMPAGLIFLOZIN or iSGLT2
Taking Empagliflozin first
Placebo then Empagliflozin 10 MGDrug
Also called EMPAGLIFLOZIN or iSGLT2
Taking the Empagliflozin in second
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | empaglifozine 10mg / wash-out / matching placebo Receives: Drug: Empagliflozin 10 MG then Placebo |
| Group 2 | Active comparator | matching placebo / wash-out / empaglifozine 10mg Receives: Drug: Placebo then Empagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-proteinuric effect
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.
Measured: 20 months
Secondary outcomes (12)
Body weight effect
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.
Measured: 20 months
Urinary sodium effect
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).
Measured: 20 months
Urinary volume effect
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.
Measured: 20 months
Blood pressure effect
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).
Measured: 20 months
eGFR effect by good profile
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)),
Measured: 20 months
eGFR effect by levels
Changes in eGFR levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Measured: 20 months
eGFR effect by serum potassium
Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Measured: 20 months
eGFR effect by serum bicarbonate
Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Measured: 20 months
eGFR effect by albuminuria
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).
Measured: 20 months
Effect on HbA1c
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).
Measured: 20 months
Magnitude of eGFR by TEAEs
Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of treatment emergent adverse events (TEAEs).
Measured: 20 months
Magnitude of eGFR by SAEs
Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of serious adverse events (SAEs).
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start25 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double blind, placebo-controlled, cross over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Guillaume FAVRE, MD-PHD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074418
- Sponsor's protocol ID
- 23-PP-12
- Acronym
- EMPA[10-20]
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 - EMPA [10-20]
- ClinicalTrials.gov ID
- NCT07074418
- Acronym / sponsor ID
- EMPA[10-20] / 23-PP-12
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease, Nephrology, eGFR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo-controlled, cross over
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Empagliflozin 10 MG then Placeboempaglifozine 10mg / wash-out / matching placebo |
| Group 2 | Active comparator | Drug: Placebo then Empagliflozin 10 MGmatching placebo / wash-out / empaglifozine 10mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MG then PlaceboAlso: EMPAGLIFLOZIN or iSGLT2Taking Empagliflozin first | Drug | Group 1 |
| Placebo then Empagliflozin 10 MGAlso: EMPAGLIFLOZIN or iSGLT2Taking the Empagliflozin in second | Drug | Group 2 |
Primary outcome
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.
12 secondary outcomes
Body weight effect
Time frame: 20 months
Urinary sodium effect
Time frame: 20 months
Urinary volume effect
Time frame: 20 months
Blood pressure effect
Time frame: 20 months
eGFR effect by good profile
Time frame: 20 months
eGFR effect by levels
Time frame: 20 months
eGFR effect by serum potassium
Time frame: 20 months
eGFR effect by serum bicarbonate
Time frame: 20 months
eGFR effect by albuminuria
Time frame: 20 months
Effect on HbA1c
Time frame: 20 months
Magnitude of eGFR by TEAEs
Time frame: 20 months
Magnitude of eGFR by SAEs
Time frame: 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume FAVRE, MD-PHD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Chronic Kidney Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume FAVRE, MD-PHD (492038428 ext. +33, favre.g@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-proteinuric effect (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.