Velcade for Proliferative Lupus Nephritis

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Rogosin Institute
• Collaborator: Weill Medical College of Cornell University
• Treatments: Bortezomib; Proteasome Inhibitors

Criteria

Inclusion Criteria:

1. ACR criteria for lupus (minimum 4 out of 11).

2. Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.

3. GFR must be greater or equal to 30 cc/min/1.73 m2.

4. Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.

5. Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.

Exclusion Criteria:

1. Serum creatinine of more than 3.0 mg/dL on repeated testing.

2. Greater than 50% fibrosis on renal biopsy.

3. Platelet count of less than 30× 109/L.

4. Absolute neutrophil count of less than 1.0 × 109/L.

5. Greater than or equal to Grade 1 peripheral neuropathy.

6. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.

7. Hypersensitivity to Velcade, boron or mannitol.

8. Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.

9. Known history of untreated positive PPD.

10. Serious complications from systemic lupus such as cerebral lupus and severe active infections.

11. Diagnosed or treated for another malignancy within 3 years of enrollment.

12. Greater than 1.5x upper limit of normal total bilirubin.