Assessment of Safety and Efficacy of SGLT2is Among LN Patients (NCT06113900) | Clinical Trial Compass
UnknownPhase 1/2
Assessment of Safety and Efficacy of SGLT2is Among LN Patients
Egypt50 participantsStarted 2023-12-01
Plain-language summary
The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.