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NCT07700940
The Efficacy of Empagliflozin on Kidney Functions in Lupus Nephritis Population
Conditions: Lupus Nephritis (LN)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 66
Sponsor: Ahmed Yehia Ismail
Location: Beni-Suef university hospital Banī Suwayf
Summary
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-controlled trials such as Empagliflozin-Kidney (EMPA-Kidney) and Dapagliflozin in Patients with Chronic Kidney Disease (DAPA-CKD) trial demonstrated the efficacy of empagliflozin and dapagliflozin, respectively, in patients with chronic kidney disease (CKD) regardless the diabetic cause of CKD, compared to placebo. EMPA-Kidney with median 2.0 years of follow-up reported that empagliflozin (EMPA) significantly (P\
Eligibility Criteria
Inclusion Criteria:
* Adults (≥ 18 years) with established biopsy-proven LN of active III, IV, overlapping III/IV, or overlapping III/V classes.
* eGFR ≥ 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.
Source: ClinicalTrials.gov (NCT07700940). StuddyBuddy aggregates publicly available trial information.