Velcade for Proliferative Lupus Nephritis

This study has been withdrawn prior to enrollment.
(No participants were enrolled.)
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01169857
First received: July 23, 2010
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.


Condition Intervention Phase
Lupus Nephritis
Proteinuria
Hematuria
Drug: 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 for Proliferative Lupus Nephritis

Resource links provided by NLM:


Further study details as provided by The Rogosin Institute:

Primary Outcome Measures:
  • Proteinuria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quantification of 24 hr urinary protein.


Secondary Outcome Measures:
  • Renal function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Serum creatinine and GFR

  • Lupus activity score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Assessment of SELENA-SLEDAI


Enrollment: 0
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Velcade Therapy Drug: Velcade
Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
Other Names:
  • Bortezomib
  • Proteasome inhibitor

Detailed Description:

This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ACR criteria for lupus (minimum 4 out of 11).
  2. Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
  3. GFR must be greater or equal to 30 cc/min/1.73 m2.
  4. Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
  5. Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.

Exclusion Criteria:

  1. Serum creatinine of more than 3.0 mg/dL on repeated testing.
  2. Greater than 50% fibrosis on renal biopsy.
  3. Platelet count of less than 30× 109/L.
  4. Absolute neutrophil count of less than 1.0 × 109/L.
  5. Greater than or equal to Grade 1 peripheral neuropathy.
  6. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
  7. Hypersensitivity to Velcade, boron or mannitol.
  8. Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
  9. Known history of untreated positive PPD.
  10. Serious complications from systemic lupus such as cerebral lupus and severe active infections.
  11. Diagnosed or treated for another malignancy within 3 years of enrollment.
  12. Greater than 1.5x upper limit of normal total bilirubin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169857

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
  More Information

No publications provided

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01169857     History of Changes
Other Study ID Numbers: X05321, 1003010960
Study First Received: July 23, 2010
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The Rogosin Institute:
Proliferative lupus nephritis
WHO class III/IV/V lupus nephritis
Proteinuria
Hematuria
Velcade
SLE
Bortezomib
Proteasome inhibitor

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Proteinuria
Hematuria
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Hemorrhage
Pathologic Processes
Bortezomib
Proteasome Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014