Pilot Study of Velcade® in IgA Nephropathy
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.
|Chronic Kidney Disease IgA Nephropathy||Drug: Bortezomib (Velcade®)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Velcade Therapy for Severe IgA Nephropathy|
- Proteinuria [ Time Frame: 1 year ]Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.
- Serum creatinine [ Time Frame: 1 year ]Preservation of renal function will be assessed.
- Laboratory safety assessment and clinical signs of infection [ Time Frame: 1 year ]Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: Velcade® therapy
Patients with greater than 1gm of proteinuria per day will receive Velcade®.
Drug: Bortezomib (Velcade®)
Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). A second cycle is to be given a month later for non-responders.
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.
Monetary compensation will be provided to study participants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103778
|Contact: Choli Hartono, MD||(212) 746-9708|
|Contact: Miriam Chung, MD||(212) 746-7647|
|United States, New York|
|The Rogosin Institute||Recruiting|
|New York, New York, United States, 10021|
|Principal Investigator: Choli Hartono, MD|
|Principal Investigator:||Choli Hartono, MD||The Rogosin Institute|