Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy.

The main objective of this study is to:

To compare use of sodium glucose linked transoprter inhibitors (SGLT2i) versus standard care in regression of chronic kidney disease in patient with lupus nephritis (LN).

To study the safety and efficacy of this drug group with use of immunosuppression and possible interaction.

Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food.

Control group will be maintained on placebo.We will follow up all patients for 12 months and compare their results.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Patients aged more than 16 year.

• Willing to sign informed consent.

• Diagnosis of SLE according to EULAR/ACR classification criteria.

• Renal biopsy showed lupus nephritis.

• Patient with eGFR > 30 ml/min/1.73m2 by cockcroft-gault equation.

Exclusion Criteria:

• Patients with eGFR <30 ml/min per 1.73 m2.

• Current pregnancy or lactation.

• Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).

• Patients refusing to participate in the study or lost follow up.

• Evidence of urinary obstruction of difficulty in voiding at screening.

• Patients who are receiving high dose diuretics or combined ACEI, Angiotensin II receptor blockers (ARBS).

• Patients who have frequent hypotensive episode or SBP <100 mmHg.