Velcade for Proliferative Lupus Nephritis
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Velcade for Proliferative Lupus Nephritis|
- Proteinuria [ Time Frame: 1 year ] [ Designated as safety issue: No ]Quantification of 24 hr urinary protein.
- Renal function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Serum creatinine and GFR
- Lupus activity score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Assessment of SELENA-SLEDAI
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: Velcade Therapy||
Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
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.
|United States, New York|
|The Rogosin Institute|
|New York, New York, United States, 10021|
|Principal Investigator:||Choli Hartono, MD||The Rogosin Institute|