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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT03458156
Eligibility Criteria:
Inclusion Criteria:
* Meeting the 1997 American College of Rheumatology (ACR) classification criteria of SLE.
* age 18-60 years.
* of either sex and of any ethnicity.
* Lupus nephritis (LN) group: (1) Receiving more than 6 months of regular treatment, 24-hour urine protein ≥ 1.0 g, serum creatinine ≥1.5 mg/dL; (2) renal biopsy: class III, IV or V LN included, and class VI excluded.
* After conventional treatment (glucocorticoid therapy and immunosuppressive drugs) prior to grouping, SLEDAI scores ≥ 10.
* Receiving 12 months of treatment while using birth control.
* Provision of informed consent.
Exclusion Criteria:
* Poor blood pressure control by drug treatment (≥ 160/100 mmHg)
* Abnormal hepatic function (a 3-fold increase in alanine aminotransferase level relative to normal liver).
* Renal failure (glomerular filtration rate \< 15 mL/min/1.73 m2).
* Severe heart and lung failure, or injury to other important organs
* Uncontrollable infection.
* Having not taken biological agents for 6 months.
* Pregnant or lactating women, or those women who are trying to get pregnant or those men who are trying to make their partners pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03458156
Study Brief:
Protocol Section:
NCT03458156