Status:
UNKNOWN
Assessment of Safety and Efficacy of SGLT2is Among LN Patients
Lead Sponsor:
Ain Shams University
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.
Detailed Description
SLE is a chronic debilitating autoimmune disorder that involves multiple organ systems either simultaneously or sequentially with relapsing and remitting course. The word 'Lupus' is a Latin term which...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06113900
Start Date
December 1 2023
End Date
January 30 2025
Last Update
November 2 2023
Active Locations (1)
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1
Ain Shams University
Alexandria, Egypt