NCT05748925CompletedPhase 4
Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients
Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients
Source: ClinicalTrials.gov · Last updated 16 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 18 Feb 2023
- Start date
- 1 Oct 2022
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Mansoura University
- Diseases
- Lupus (SLE)
- NCT number
- NCT05748925
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 84
- From 1 Oct 2022 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are receiving high dose diuretics or combined ACEI, Angiotensin II receptor blockers (ARBS).
Other illness
- Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).
Lab values
- Patients with eGFR \<30 ml/min per 1.73 m2.
Other
- Current pregnancy or lactation.
- Patients refusing to participate in the study or lost follow up.
- Evidence of urinary obstruction of difficulty in voiding at screening.
- Patients who have frequent hypotensive episode or SBP \<100 mmHg.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urology and Nephrology Center Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Unknown status |
Related publications
- Dapagliflozin in lupus nephritis: renal and hematologic outcomes from a randomized controlled trial.Clin Kidney J · 2026 · PMID 42549085
This page is information, not medical advice. Discuss any trial with your doctor.