Velcade for Proliferative Lupus Nephritis

Phase 4

Withdrawn

• Conditions: Lupus Nephritis; Proteinuria; Hematuria
• Interventions: Drug: Velcade

• Registration Number: NCT01169857
• Lead Sponsor: The Rogosin Institute

Brief 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.

Study Timeline

• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Study Start: 2010-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-24
• Primary Completion: 2012-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Velcade Therapy	Velcade	-

Primary Outcome Measures

Name	Time	Method
Proteinuria	1 year	Quantification of 24 hr urinary protein.

Secondary Outcome Measures

Name	Time	Method
Renal function	1 year	Serum creatinine and GFR
Lupus activity score	1 year	Assessment of SELENA-SLEDAI

Trial Locations

Locations (1)

The Rogosin Institute; 🇺🇸 New York, New York, United States