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Pilot Study of Velcade® in IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT01103778
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : October 17, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute

Brief 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.


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

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Velcade Therapy for Severe IgA Nephropathy
Study Start Date : July 2010
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : April 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Bortezomib

Arm Intervention/treatment
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).
Other Names:
  • Velcade®
  • Bortezomib




Primary Outcome Measures :
  1. Proteinuria [ Time Frame: Baseline and 1 year ]
    Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.

  2. Number of Participants With Complete Remission, Partial Response, or no Response. [ Time Frame: 1 year ]

    Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection.

    Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection.



Secondary Outcome Measures :
  1. Serum Creatinine [ Time Frame: Baseline and 1 year ]
    Preservation of renal function will be assessed.

  2. Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication. [ Time Frame: 1 year ]
    Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103778


Locations
United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Investigators
Principal Investigator: Choli Hartono, MD The Rogosin Institute
  Study Documents (Full-Text)

Documents provided by The Rogosin Institute:

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01103778     History of Changes
Other Study ID Numbers: X05320
1001010854 ( Other Identifier: Weill Cornell Medical College IRB )
First Posted: April 15, 2010    Key Record Dates
Results First Posted: October 17, 2018
Last Update Posted: November 16, 2018
Last Verified: October 2018

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

Additional relevant MeSH terms:
Bortezomib
Kidney Diseases
Renal Insufficiency, Chronic
Glomerulonephritis, IGA
Urologic Diseases
Renal Insufficiency
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents