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.
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 doses of Velcade to induce clinical remission.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
The Rogosin Institute
New York, New York, United States
Proteinuria
Quantification of 24 hr urinary protein.
Time frame: 1 year
Renal function
Serum creatinine and GFR
Time frame: 1 year
Lupus activity score
Assessment of SELENA-SLEDAI
Time frame: 1 year
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