NCT01169857

Velcade for Proliferative Lupus Nephritis

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Rogosin Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Lupus Nephritis
• Proteinuria
• Hematuria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2010-07-26
• Last updated: 2012-04-24

Locations

1 site across 1 country: United States