Assessment of Safety and Efficacy of SGLT2is Among LN Patients (NCT06113900) | Clinical Trial Compass
UnknownPhase 1/2
Assessment of Safety and Efficacy of SGLT2is Among LN Patients
Egypt50 participantsStarted 2023-12-01
Plain-language summary
The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients aged more than 18 year.
* Patients with confirmed SLE according to EULAR/ACR classification criteria.
* Patients with LN ( persistent proteinuria \> 2 gm per day or greater than 3+ by dipstick, and/or cellular casts including red cell, hemoglobin, granular, tubular or mixed \& "active urinary sediment" (\>5 RBC/hpf, \>5 WBC/hpf in the absence of infection, or cellular casts limited to RBC or WBC casts )
* Patient with e GFR \> 25 ml/min/1.73m2 by CKD-EPI equation.
Exclusion Criteria:
* Patients with an allergy or intolerance to Dapagliflozin or any prior SGLT2i exposure within 1 month before screening.
* Medical history of chronic disease (Severe respiratory distress, gastrointestinal tract lesions \& chronic liver disease)
* Patients with recurrent genitourinary infections.
* Patient with proteinuria \< 2gm.
* Patient who show response to immune therapy in proteinuria reduction \> 50%.
* Patient with Lupus in induction phase.
* Patient on steroids \> 30 mg daily dose.
* Patients with diabetes mellitus.
* Patients with severe infection requiring antibiotics within 1 month before screening.
* Patients with malignant diseases.
* Pregnant or breast-feeding women.
* Patients with eGFR \< 25 ml/min/1.73m2 or undergoing dialysis therapy