Velcade for Proliferative Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Velcade for Proliferative Lupus Nephritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01169857
• Other study ID #: X05321
• Secondary ID: 1003010960
• Status: Withdrawn
• Phase: Phase 4
• First received: July 23, 2010
• Last updated: April 23, 2012
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematuria
• Lupus Nephritis
• Nephritis
• Proteinuria

Intervention

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.

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Rogosin Institute	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteinuria	Quantification of 24 hr urinary protein.	1 year	No
Secondary	Renal function	Serum creatinine and GFR	1 year	Yes
Secondary	Lupus activity score	Assessment of SELENA-SLEDAI	1 year	Yes