Back to resultsVelcade for Proliferative Lupus Nephritis
Primary Purpose
Lupus Nephritis, Proteinuria, Hematuria
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Velcade
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring Proliferative lupus nephritis, WHO class III/IV/V lupus nephritis, Proteinuria, Hematuria, Velcade, SLE, Bortezomib, Proteasome inhibitor
Eligibility Criteria
Inclusion Criteria:
- ACR criteria for lupus (minimum 4 out of 11).
- Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
- GFR must be greater or equal to 30 cc/min/1.73 m2.
- Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
- Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
Exclusion Criteria:
- Serum creatinine of more than 3.0 mg/dL on repeated testing.
- Greater than 50% fibrosis on renal biopsy.
- Platelet count of less than 30× 109/L.
- Absolute neutrophil count of less than 1.0 × 109/L.
- Greater than or equal to Grade 1 peripheral neuropathy.
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
- Hypersensitivity to Velcade, boron or mannitol.
- Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
- Known history of untreated positive PPD.
- Serious complications from systemic lupus such as cerebral lupus and severe active infections.
- Diagnosed or treated for another malignancy within 3 years of enrollment.
- Greater than 1.5x upper limit of normal total bilirubin.
Sites / Locations
- The Rogosin Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Velcade Therapy
Arm Description
Outcomes
Primary Outcome Measures
Proteinuria
Quantification of 24 hr urinary protein.
Secondary Outcome Measures
Renal function
Serum creatinine and GFR
Lupus activity score
Assessment of SELENA-SLEDAI
Full Information
NCT ID
NCT01169857
First Posted
July 23, 2010
Last Updated
April 23, 2012
Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT01169857
Brief Title
Velcade for Proliferative Lupus Nephritis
Official Title
Velcade for Proliferative Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled.
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis, Proteinuria, Hematuria
Keywords
Proliferative lupus nephritis, WHO class III/IV/V lupus nephritis, Proteinuria, Hematuria, Velcade, SLE, Bortezomib, Proteasome inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Velcade Therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Velcade
Other Intervention Name(s)
Bortezomib, Proteasome inhibitor
Intervention Description
Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
Primary Outcome Measure Information:
Title
Proteinuria
Description
Quantification of 24 hr urinary protein.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Renal function
Description
Serum creatinine and GFR
Time Frame
1 year
Title
Lupus activity score
Description
Assessment of SELENA-SLEDAI
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ACR criteria for lupus (minimum 4 out of 11).
Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
GFR must be greater or equal to 30 cc/min/1.73 m2.
Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
Exclusion Criteria:
Serum creatinine of more than 3.0 mg/dL on repeated testing.
Greater than 50% fibrosis on renal biopsy.
Platelet count of less than 30× 109/L.
Absolute neutrophil count of less than 1.0 × 109/L.
Greater than or equal to Grade 1 peripheral neuropathy.
Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
Hypersensitivity to Velcade, boron or mannitol.
Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
Known history of untreated positive PPD.
Serious complications from systemic lupus such as cerebral lupus and severe active infections.
Diagnosed or treated for another malignancy within 3 years of enrollment.
Greater than 1.5x upper limit of normal total bilirubin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choli Hartono, MD
Organizational Affiliation
The Rogosin Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Velcade for Proliferative Lupus Nephritis
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