Pilot Study of Velcade® in IgA Nephropathy

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.

Inclusion criteria

• Male or female, 18 years of age or older.
• Must have IgA nephropathy documented by kidney biopsy.
• Must have greater than 1gm of proteinuria a day.
• 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

• Low platelet count and neutrophil count within certain limits defined for enrollment.
• Underlying peripheral neuropathy.
• 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.
• Allergic to VELCADE®, boron or mannitol.
• Female subjects who are pregnant or breast-feeding.
• Recent use of investigational drug within 14 days before enrollment.
• Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.
• 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.