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Velcade Therapy for Severe IgA Nephropathy

Phase 4
18 Years
Open (Enrolling)
Chronic Kidney Disease, IgA Nephropathy

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Trial Information

Velcade Therapy for Severe IgA Nephropathy

This exploratory single center, open-label, single treatment group assignment, safety and
efficacy study will enroll 10 patients with severe IgA nephropathy. Subjects will receive 1
cycle of Velcade® to induce clinical remission. Follow-up visits will occur monthly for a

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

Monetary compensation will be provided to study participants.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Choli Hartono, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Rogosin Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

  • Chronic Kidney Disease
  • IgA Nephropathy
  • Chronic kidney disease
  • IgA nephropathy
  • Velcade®
  • Proteinuria
  • Bortezomib
  • Proteasome inhibitor
  • Glomerulonephritis, IGA
  • Kidney Diseases
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic



The Rogosin Institute New York, New York  10021