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The Efficacy of Empagliflozin on Kidney Functions in Lupus Nephritis Population

RecruitingPhase 4Ages 18 Years - 65 YearsAllAhmed Yehia Ismail
NCT07700940 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Systemic lupus erythematosis (SLE) is a chronic, most probably auto-immune multisystem disease marked by relapsing-remitting course and the formation of a range of autoantibodies. SLE patients present with serious renal (lupus nephritis (LN)), cardiopulmonary, or nervous manifestation. LN occurs in 40%-70% of SLE cases during the first 10 years of disease and is marked by the presence of proteinuria (hallmark). A novel class of medications had been extracted from phlorizin and indicated for the treatment of type 2 diabetes (T2D), referred to as Sodium glucose cotransporter 2 (SGLT-2) inhibitors. They act by decreasing glucose reabsorption in the proximal renal tubules (SGLT2). Previous studies proved that SGLT2 inhibitors resulted in decreased postprandial hyperglycemia, enhanced glycemic control, reduced body weight and blood pressure, and albuminuria in those with T2D. Large placebo-c

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults (โ‰ฅ 18 years) with established biopsy-proven LN of active III, IV, overlapping III/IV, or overlapping III/V classes. * eGFR โ‰ฅ 30 ml.min1.1.73m-2, * Urinary protein creatinine ratio (uPCR) \> 1000 mg/g. Exclusion Criteria: * Subjects with serious hypersensitivity (angioedema and/or anaphylaxis) to EMPA. * eGFR \< 30 ml.min-1.1.73m-2. * uPCR \< 1000 mg/g. * Type 1 or 2 diabetes. * Aterial fibrillation. * Hepatic impairment \[defined as alanine transaminase or aspartate transaminase \>3 times the upper limit of normal (ULN) or total bilirubin \>2 times the ULN at the time of enrolment\]. * Any condition outside the renal and cardiovascular study area with a life expectancy of \< 6 months based on care provider's clinical judgment. * Those who enrolled in an experimental study in the previous 6 months.
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What it tests

  • Empagliflozin (25 Mg Tab) along with standard medical therapy
  • Placebo and standard of care
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Where

1 site
Beni-Suef university hospital
Banฤซ Suwayf, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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