CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 84 enrolled
Drug / intervention
dapagliflozin +1 moredrug
Likely dose
dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05748925
NCT05748925Phase 4Completed

Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients

Mansoura University·interventional·Posted Mar 1, 2023·Updated Apr 16, 2025

In Brief

A Phase 4 clinical trial evaluating dapagliflozin and placebo for SLE and 2 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMar 1, 2023
Enrollment StartOct 1, 2022
Primary CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.3 years ago

Interventions

dapagliflozindrug

The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.

placebodrug

Control group: will be maintained on their medication