The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to induce complete or partial remission in patients with severe IgA nephropathy. The secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.
This exploratory single center, open-label, single treatment group assignment, safety and efficacy study will enroll 15 patients with severe IgA nephropathy. Subjects will receive 1 cycle of Velcade® to induce clinical remission. Follow-up visits will occur monthly for a year. For this pilot study, the proportion of patients with clinical remission or partial response will be analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
The Rogosin Institute
New York, New York, United States
Proteinuria
Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.
Time frame: Baseline and 1 year
Number of Participants With Complete Remission, Partial Response, or no Response.
Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection. Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection.
Time frame: 1 year
Serum Creatinine
Preservation of renal function will be assessed.
Time frame: Baseline and 1 year
Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.
Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed.
Time frame: 1 year
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