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SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease

RecruitingPhase 2Ages 18 Years - anyAllThe University of Hong Kong
NCT06155604 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Lupus nephritis (LN) is a common manifestation in patients with systemic lupus erythematosus (SLE), and is an important cause of acute kidney injury and chronic kidney disease (CKD). Although the standard-of-care treatments for active severe LN are effective, a substantial proportion of LN patients still develop CKD and eventually end-stage kidney disease (ESKD). Cardiovascular complications are common and is a leading cause of death in SLE and LN patients. It is well recognized that LN patients had multiple risk factors for cardiovascular complications such as diabetes mellitus (DM), dyslipidaemia and vascular inflammation. Sodium-glucose co-transporter 2 (SGLT2) inhibitor are initially developed as an oral anti-diabetic agent and has shown to be effective in glycaemic control, has benefits in lipid metabolism, cardiovascular and renal outcomes, and also well tolerated by patients. Var

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with biopsy-proven Class III or IV or V LN according to the ISN/RPS 2003 classification 2. Patients with CKD (eGFR 15-60mL/min) 3. Patients in quiescent disease (defined as SLEDAI score \<4 with no points in the renal domain) 4. Patients on a stable dose of prednisolone (PRED 5-7.5 mg/D) alone or in combination with MMF (\<=1.5 g/D) or AZA (\<=150 mg/D) in the past 3 months Exclusion Criteria: 1. Patients with biopsy-proven glomerulonephritis other than LN or hereditary kidney diseases 2. Patients with type 1 diabetes mellitus (DM) 3. Patients with stage 5 CKD or ESKD on renal replacement therapy 4. Patients with frequent urinary tract infections 5. Patients with history of ketoacidosis
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What it tests

  • Dapagliflozin 10mg Tab
  • Standard maintenance therapy
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Where

1 site
Queen Mary Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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