WithdrawnPhase 4

Velcade for Proliferative Lupus Nephritis

Stopped: No participants were enrolled.

United States0Started 2010-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Proteinuria

Timeframe: 1 year

Trial details

NCT IDNCT01169857

SponsorThe Rogosin Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Lupus Nephritis trials