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Pilot Study of Velcade® in IgA Nephropathy

This study is currently recruiting participants.
Verified November 2012 by The Rogosin Institute
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01103778
First received: April 13, 2010
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
IgA Nephropathy
 Drug: Bortezomib (Velcade®)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Velcade Therapy for Severe IgA Nephropathy

Resource links provided by NLM:

Drug Information available for: Bortezomib
U.S. FDA Resources

Further study details as provided by The Rogosin Institute:

Primary Outcome Measures:
  • Proteinuria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.


Secondary Outcome Measures:
  • Serum creatinine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Preservation of renal function will be assessed.

  • Laboratory safety assessment and clinical signs of infection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed


Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Velcade® therapy
Patients with greater than 1gm of proteinuria per day will receive Velcade®.
 Drug: Bortezomib (Velcade®)
Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). A second cycle is to be given a month later for non-responders.
Other Names:
  • Velcade®
  • Bortezomib

Detailed Description:

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 year.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103778

Contacts
Contact: Choli Hartono, MD (212) 746-9708
Contact: Miriam Chung, MD (212) 746-7647

Locations
United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Principal Investigator: Choli Hartono, MD            
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Investigators
Principal Investigator: Choli Hartono, MD The Rogosin Institute
  More Information

No publications provided

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01103778     History of Changes
Other Study ID Numbers: X05320, 1001010854
Study First Received: April 13, 2010
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Rogosin Institute:
Chronic kidney disease
IgA nephropathy
Velcade®
 Proteinuria
Bortezomib
Proteasome inhibitor

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
 Renal Insufficiency
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013