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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT01015456
Eligibility Criteria:
Inclusion Criteria:
* age 16 years of above at the time of screening
* ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
* Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
* Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (\>90% chronic irreversible scarring)
* Relapse or resistant to (3 consecutive doses) IVCY
* Resistant lupus or Relapse lupus nephritis defined as follows:
* Increase in serum creatinine \>/= 0.3 mg/dl or
* Increase in proteinuria \> 1.5 g/day (which must have improved by ≥ 50% in the preceding 3 months)
* Life-time cumulative dose of IVCY \> 6 grams
* Female patients of childbearing potential must have a negative serum pregnancy
Exclusion Criteria:
Relates to SLE
* Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%
* Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR \< 30 ml/min(except creatinine clearance or MDRD-GFR \> 50 ml/min in the 12 weeks prior to screening)
* History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.
* Severe extra-renal organ involvement
Related to Treatment
* Previous of any Mycophenolate groups in the 6 months prior to screening
* Treatment with any investigational drugs in the 3 months prior to screening
Related to General Health
* Pregnancy or breast feeding mothers.
* Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.
* Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
* History of cancer, including solid tumors, hematological malignancies and carcinoma.
* Evidence of current abuse of drugs or alcohol.
Related to Laboratory Findings
* Neutrophile \< 1,500/mm3, Hb \< 7g/L, Platelet \< 50,000/mm3 (except active SLE)
* Positive HBsAg or anti-HCV or anti-HIV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT01015456
Study Brief:
Protocol Section:
NCT01015456