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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT03920059
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 year
* Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE
* Active lupus nephritis (both new and flare patients can be included) defined as:
* Within 16 weeks of randomization, had Biopsy-proven ISN class III or IV \[exclude III(c), IV-S(c) and IV-G(c). Patients are permitted to have co-existing class V and
* At screening day, has urine protein creatinine ratio (UPCR) or 24-hour urinary protein ≥ 1.0 g/g or g/day
Exclusion Criteria:
* Pregnancy or breast feeding
* Child-bearing age women who refuse to use effective birth-control
* Poor compliance
* Estimated-GFR \< 20 mL/min/1.73 m2
* Crescentic glomeruli more than 30 percent
* Severe extra-renal involvement of SLE
* History of severe allergic reactions or adverse effects to MMF
* Uncontrolled concomitant disease
* Known active, clinically significant infection of any kind
* History of serious recurrent or chronic infection
* History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)
* Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening
* Treatment with more than 1 g cyclophosphamide within the past 24 weeks
* Receipt more than 3 g of IV pulse methylprednisolone within the past 12 weeks
* Receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks
* Treatment with MMF at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks
* On treatment with Tacrolimus or Cyclosporine on the day of screening
* Treatment with any biologic B-cell depleting therapy (e.g. anti CD-20, anti CD 22) within 52 weeks
* Receiving concomitant medication interfering PK of MPA
* Cholestyramine
* Rifampin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03920059
Study Brief:
Protocol Section:
NCT03920059