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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01316133
Eligibility Criteria:
Inclusion Criteria:
* Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
* Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
* Patients with refractory lupus nephritis
* Proteinuria ≥ 0.5 g/day
* Patients who took steroid ≥ 20 mg/day over one month prior to the study
* Patients who failed a first-line therapy (non-responders to steroid monotherapy)
Exclusion Criteria:
* Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
* Patients who received tacrolimus in the past (excluding drugs for external use)
* Patients who used other immunosuppressants within 4 weeks before initiation of the study
* Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
* Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
* Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
* Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
* Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01316133
Study Brief:
Protocol Section:
NCT01316133