NCT01103778

Pilot Study of Velcade® in IgA Nephropathy

Velcade Therapy for Severe IgA Nephropathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: The Rogosin Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Kidney Disease
• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Bortezomib (Velcade®)	Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).

Timeline

• Start date: 2010-07-01
• Primary completion: 2017-04-17
• Completion: 2017-04-17
• First posted: 2010-04-15
• Last updated: 2018-11-16
• Results posted: 2018-10-17

Locations

1 site across 1 country: United States