Study Stopped
No participants were enrolled.
Velcade for Proliferative Lupus Nephritis
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2010
CompletedFirst Posted
Study publicly available on registry
July 26, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 24, 2012
April 1, 2012
2 years
July 23, 2010
April 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proteinuria
Quantification of 24 hr urinary protein.
1 year
Secondary Outcomes (2)
Renal function
1 year
Lupus activity score
1 year
Study Arms (1)
Velcade Therapy
EXPERIMENTALInterventions
Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Rogosin Institutelead
- Weill Medical College of Cornell Universitycollaborator
Study Sites (1)
The Rogosin Institute
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Choli Hartono, MD
The Rogosin Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2010
First Posted
July 26, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
April 24, 2012
Record last verified: 2012-04