NCT07074418

Brief 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 potential renal protective effect.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

June 30, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

June 30, 2025

Last Update Submit

January 21, 2026

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney DiseaseNephrologyeGFR

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 months

Secondary Outcomes (12)

  • Body weight effect

    20 months

  • Urinary sodium effect

    20 months

  • Urinary volume effect

    20 months

  • Blood pressure effect

    20 months

  • eGFR effect by good profile

    20 months

  • +7 more secondary outcomes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

empaglifozine 10mg / wash-out / matching placebo

Drug: Empagliflozin 10 MG then Placebo

Group 2

ACTIVE COMPARATOR

matching placebo / wash-out / empaglifozine 10mg

Drug: Placebo then Empagliflozin 10 MG

Interventions

Empagliflozin 10 MG then PlaceboDRUG

Taking Empagliflozin first

Also known as: EMPAGLIFLOZIN or iSGLT2
Group 1
Placebo then Empagliflozin 10 MGDRUG

Taking the Empagliflozin in second

Also known as: EMPAGLIFLOZIN or iSGLT2
Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, 06000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent ESNAULT, MD-PHD

    CHU NICE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent ESNAULT, MD-PHD

CONTACT

492038800esnault.v@chu-nice.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, double blind, placebo-controlled, cross over
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 20, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

FR(1)