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:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT04146220
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years of both sexes
2. Diagnosed case of systemic lupus erythematosus (SLE) as per ACR criteria
3. Patients consenting to participate in the study
4. Class III/IV lupus nephritis (LN) as evidenced by:
* Confirmed proteinuria ≥ 500 mg/24 hours when assessed by 24-hour urine collection And
* High titer anti-dsDNA (\>75 U/ml) and low C3 (\<0.9 g/l) and/or C4 (\<0.1 g/l) Or
* Kidney biopsy: with a histologic diagnosis of class III or IV lupus nephritis (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis)
Exclusion Criteria:
1. Subjects not giving written informed consent
2. Pregnant or lactating women
3. Patient willing to be treated with MMF rather than CYC
4. Had taken CYC within 4 weeks prior to screening
5. Had taken \>15 mg/day of prednisolone (or equivalent) for a period of \>10 days during the previous month
6. Renal thrombotic microangiopathy
7. Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2 at screening
8. Dialysis dependent patients, currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period
9. A previous kidney transplant or planned transplant within study treatment period
10. Altered liver function (alanine aminotransferase greater than 2.5 times the upper limit of normal) at screening and confirmed before randomization
11. Malignancy
12. Lymphoproliferative disease or previous total lymphoid irradiation
13. Active bleeding disorders
14. Active tuberculosis (TB)
15. Diabetes mellitus
16. Any known hypersensitivity or contraindication to CYC, corticosteroids or any components of these drug products
17. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g., scleroderma with significant pulmonary hypertension; any condition for which additional immunosuppression is indicated)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04146220
Study Brief:
Protocol Section:
NCT04146220