Pilot Study of Velcade® in IgA Nephropathy

• Status: Completed
• Trial end date: 2017-04-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Rogosin Institute
• Collaborator: Weill Medical College of Cornell University
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

1. Male or female, 18 years of age or older.

2. Must have IgA nephropathy documented by kidney biopsy.

3. Must have greater than 1gm of proteinuria a day.

4. Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.

Exclusion Criteria:

1. Low platelet count and neutrophil count within certain limits defined for enrollment.

2. Underlying peripheral neuropathy.

3. Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

4. Allergic to VELCADE®, boron or mannitol.

5. Female subjects who are pregnant or breast-feeding.

6. Recent use of investigational drug within 14 days before enrollment.

7. Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.

8. Diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.