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:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT06155604
Eligibility Criteria:
Inclusion Criteria:
1. Patients with biopsy-proven Class III or IV or V LN according to the ISN/RPS 2003 classification
2. Patients with CKD (eGFR 15-60mL/min)
3. Patients in quiescent disease (defined as SLEDAI score \<4 with no points in the renal domain)
4. Patients on a stable dose of prednisolone (PRED 5-7.5 mg/D) alone or in combination with MMF (\<=1.5 g/D) or AZA (\<=150 mg/D) in the past 3 months
Exclusion Criteria:
1. Patients with biopsy-proven glomerulonephritis other than LN or hereditary kidney diseases
2. Patients with type 1 diabetes mellitus (DM)
3. Patients with stage 5 CKD or ESKD on renal replacement therapy
4. Patients with frequent urinary tract infections
5. Patients with history of ketoacidosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06155604
Study Brief:
Protocol Section:
NCT06155604