Assessment of Safety and Efficacy of SGLT2is Among LN Patients

• Status: Not yet recruiting
• Trial end date: 2025-01-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ain Shams University
• Treatments: Dapagliflozin; Empagliflozin

Criteria

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