Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT06113900
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06113900
Study Brief:
Protocol Section:
NCT06113900