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Desensitization in Kidney Transplantation

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
E. Steve Woodle, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00908583
First received: May 26, 2009
Last updated: March 15, 2013
Last verified: March 2013
History of Changes

May 26, 2009
March 15, 2013
May 2009
November 2012   (final data collection date for primary outcome measure)
Efficacy: Proportion of patients with reduction in cytotoxic Panel-Reactive Antibody (PRA) of 50% or greater. safety: Incidence of grade 3 non hematologic toxicities. [ Time Frame: Study Day 62 ] [ Designated as safety issue: Yes ]
Efficacy: Proportion of patients with reduction in cytotoxic PRA of 50% or greater. safety: Incidence of grade 3 non hematologic toxicities. [ Time Frame: Study Day 62 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00908583 on ClinicalTrials.gov Archive Site
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Desensitization in Kidney Transplantation
Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation

To determine if deletional strategies will provide effective desensitization.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HLA Sensitization
Drug: Deletional therapy/plasmapheresis
B lymphocyte/plasma cell deletional therapy will be administered
  • Experimental: Phase 1, two stages
    Deletional, two stage approach with terminal plasmapheresis
    Intervention: Drug: Deletional therapy/plasmapheresis
  • Experimental: Phase 2, two stages
    Deletional, two stage approach with terminal plasmapheresis
    Intervention: Drug: Deletional therapy/plasmapheresis
  • Experimental: Phase 3
    Deletional, two stage approach with terminal plasmapheresis
    Intervention: Drug: Deletional therapy/plasmapheresis
  • Experimental: Phase 4, single stage
    Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
    Intervention: Drug: Deletional therapy/plasmapheresis
  • Experimental: Phase 5, single stage
    Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
    Intervention: Drug: Deletional therapy/plasmapheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 65
  • Voluntary written informed consent
  • Patient on deceased donor wait list with a current or peak cytotoxic or calculated PRA > 25%

Exclusion Criteria:

  • Myocardial infarction within 6 months
  • Patient received investigational drug within 14 days prior to enrollment
  • Serious medical or psychological illness
  • Diagnosed with malignancy within three years, except with cancers with very high cure rates
  • Absolute neutrophil count (ANC) < 1000
  • Receipt of live vaccine within 4 weeks of study entry
  • Female subject that is breast feeding
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00908583
X05295
No
E. Steve Woodle, University of Cincinnati
University of Cincinnati
Millennium Pharmaceuticals, Inc.
Principal Investigator: E. Steve Woodle, MD University of Cincinnati
University of Cincinnati
March 2013

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