Status:
WITHDRAWN
Velcade for Proliferative Lupus Nephritis
Lead Sponsor:
The Rogosin Institute
Collaborating Sponsors:
Weill Medical College of Cornell University
Conditions:
Lupus Nephritis
Proteinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.
Detailed Description
This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 dose...
Eligibility Criteria
Inclusion
- ACR criteria for lupus (minimum 4 out of 11).
- Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
- GFR must be greater or equal to 30 cc/min/1.73 m2.
- Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
- Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
Exclusion
- Serum creatinine of more than 3.0 mg/dL on repeated testing.
- Greater than 50% fibrosis on renal biopsy.
- Platelet count of less than 30× 109/L.
- Absolute neutrophil count of less than 1.0 × 109/L.
- Greater than or equal to Grade 1 peripheral neuropathy.
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
- Hypersensitivity to Velcade, boron or mannitol.
- Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
- Known history of untreated positive PPD.
- Serious complications from systemic lupus such as cerebral lupus and severe active infections.
- Diagnosed or treated for another malignancy within 3 years of enrollment.
- Greater than 1.5x upper limit of normal total bilirubin.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01169857
Start Date
August 1 2010
End Date
December 1 2012
Last Update
April 24 2012
Active Locations (1)
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1
The Rogosin Institute
New York, New York, United States, 10021