drugset / Trial / NCT05748925

Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

NCT05748925

Phase 4 Completed 84 enrolled Mansoura University
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2022-10-01
Primary completion
2024-01-01
Completion
2024-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule 10 mg
Comparator Dapagliflozin Small molecule 10 mg/kg
Comparator Dapagliflozin Small molecule 25 mg