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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This study has been withdrawn prior to enrollment.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
History of Changes

July 23, 2010
April 23, 2012
August 2010
August 2012   (final data collection date for primary outcome measure)
Proteinuria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quantification of 24 hr urinary protein.
Same as current
Complete list of historical versions of study NCT01169857 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Velcade for Proliferative Lupus Nephritis
Velcade for Proliferative Lupus Nephritis

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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lupus Nephritis
  • Proteinuria
  • Hematuria
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
Experimental: Velcade Therapy
Intervention: Drug: Velcade
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01169857
X05321, 1003010960
No
The Rogosin Institute
The Rogosin Institute
Weill Medical College of Cornell University
Principal Investigator: Choli Hartono, MD The Rogosin Institute
The Rogosin Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP