RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Empagliflozin 10 MG then Placebo for Chronic Kidney Diseases

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.

Official registry: https://clinicaltrials.gov/study/NCT07074418 · Centre Hospitalier Universitaire de Nice · enrollment listed as 34

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Empagliflozin 10 MG then Placebo, or Placebo then Empagliflozin 10 MG. The registry lists allocation as randomized. The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure.

They plan to enroll about 34 people at Nice. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 - EMPA [10-20]

Interventions: Empagliflozin 10 MG then Placebo, Placebo then Empagliflozin 10 MG

Primary outcome (registry wording): Anti-proteinuric effect

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
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 the registry excludes

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,
vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French)

Public study contact (from the registry)

Guillaume FAVRE, MD-PHD

492038428

favre.g@chu-nice.fr

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

CHU Nice - Hôpital Pasteur 2 — Nice, Alpes-Maritimes, France (recruiting)

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FAQ about this NCT record

Is NCT07074418 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07074418?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07074418?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary