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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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