Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
Recruiting · NCT07074418 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Empagliflozin 10 MG then PlaceboPlacebo then Empagliflozin 10 MG
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
- 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
- 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).
Where it is running
1 location listed.
- CHU Nice - Hôpital Pasteur 2 - Nice, Alpes-Maritimes, France