Pilot Study of Velcade® in IgA Nephropathy

Status Completed

Clinical Trial Summary

The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to induce complete or partial remission in patients with severe IgA nephropathy.

The secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.

Clinical Trial Description

This exploratory single center, open-label, single treatment group assignment, safety and efficacy study will enroll 15 patients with severe IgA nephropathy. Subjects will receive 1 cycle of Velcade® to induce clinical remission. Follow-up visits will occur monthly for a year.

For this pilot study, the proportion of patients with clinical remission or partial response will be analyzed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01103778
Study type	Interventional
Source	The Rogosin Institute
Contact
Status	Completed
Phase	Phase 4
Start date	July 2010
Completion date	April 17, 2017

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