Velcade for Proliferative Lupus Nephritis

This study is currently recruiting participants.
Verified by The Rogosin Institute, February 2011
First Received: July 23, 2010 Last Updated: February 10, 2011

The Rogosin Institute
Weill Medical College of Cornell University
Information provided by:
The Rogosin Institute Identifier:

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.

Condition Intervention Phase
Lupus Nephritis
Drug: Velcade Phase IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Control: Uncontrolled
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment Official Title: Velcade for Proliferative Lupus Nephritis

Further study details as provided by The Rogosin Institute:
Primary Outcome Measures:

  • Proteinuria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quantification of 24 hr urinary protein.

Secondary Outcome Measures:

  • 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

Estimated Enrollment: 14
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

Velcade Therapy:
Experimental Intervention: Drug: Velcade




Drug: Velcade
Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
Other Names:

  • Bortezomib
  • Proteasome inhibitor


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 doses of Velcade to induce clinical remission.