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Pilot Study of Velcade® in IgA Nephropathy

NCT01103778 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-11-16

Study results available
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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.

Conditions

Interventions

DRUG

Bortezomib (Velcade®)

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

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • The Rogosin Institute

    lead OTHER

Principal Investigators

  • Choli Hartono, MD · The Rogosin Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-04-17
Completion
2017-04-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103778 on ClinicalTrials.gov