Velcade for Proliferative Lupus Nephritis
Withdrawn before enrolling · Phase 4
Conditions studied: Lupus Nephritis, Proteinuria, Hematuria
In brief
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.
Key facts
- Study ID
- NCT01169857
- Run by
- The Rogosin Institute
- People needed
- 0
- Starts
- 2010-08-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2012-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The Rogosin Institute — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.