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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT01206569
Eligibility Criteria:
Inclusion Criteria:
* Age over 18 with informed consent.
* Fulfill the revised American College of Rheumatology criteria for SLE
* Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
* Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
* NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine \<15% above the base-line value.
* Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.
Exclusion Criteria:
* Abnormal liver function tests
* Hepatitis B surface antigen or hepatitis C antibody positive
* Diabetic
* Receiving NSAID or other agents known to influence urinary
* Protein excretion
* Allergic or intolerant to macrolide antibiotics or tacrolimus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01206569
Study Brief:
Protocol Section:
NCT01206569