Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin 10 MG then Placebo, Placebo then Empagliflozin 10 MG.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 - EMPA [10-20]
Overview
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.
Interventions
- Drug Empagliflozin 10 MG then Placebo
Taking Empagliflozin first - Drug Placebo then Empagliflozin 10 MG
Taking the Empagliflozin in second
Primary outcome measures
- Anti-proteinuric effect [Time frame: 20 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Nice - Hôpital Pasteur 2 — Nice
Identifiers
NCT: NCT07074418 · 23-PP-12