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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT01169857
Eligibility Criteria:
Inclusion Criteria:
1. ACR criteria for lupus (minimum 4 out of 11).
2. Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
3. GFR must be greater or equal to 30 cc/min/1.73 m2.
4. Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
5. Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
Exclusion Criteria:
1. Serum creatinine of more than 3.0 mg/dL on repeated testing.
2. Greater than 50% fibrosis on renal biopsy.
3. Platelet count of less than 30× 109/L.
4. Absolute neutrophil count of less than 1.0 × 109/L.
5. Greater than or equal to Grade 1 peripheral neuropathy.
6. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
7. Hypersensitivity to Velcade, boron or mannitol.
8. Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
9. Known history of untreated positive PPD.
10. Serious complications from systemic lupus such as cerebral lupus and severe active infections.
11. Diagnosed or treated for another malignancy within 3 years of enrollment.
12. Greater than 1.5x upper limit of normal total bilirubin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01169857
Study Brief:
Protocol Section:
NCT01169857