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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
  Purpose

To determine if deletional strategies will provide effective desensitization.


Condition Intervention Phase
HLA Sensitization
 Drug: Deletional therapy/plasmapheresis
 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: Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: May 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1, two stages
Deletional, two stage approach with terminal plasmapheresis
 Drug: Deletional therapy/plasmapheresis
B lymphocyte/plasma cell deletional therapy will be administered
Experimental: Phase 2, two stages
Deletional, two stage approach with terminal plasmapheresis
 Drug: Deletional therapy/plasmapheresis
B lymphocyte/plasma cell deletional therapy will be administered
Experimental: Phase 3
Deletional, two stage approach with terminal plasmapheresis
 Drug: Deletional therapy/plasmapheresis
B lymphocyte/plasma cell deletional therapy will be administered
Experimental: Phase 4, single stage
Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
 Drug: Deletional therapy/plasmapheresis
B lymphocyte/plasma cell deletional therapy will be administered
Experimental: Phase 5, single stage
Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
 Drug: Deletional therapy/plasmapheresis
B lymphocyte/plasma cell deletional therapy will be administered

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908583

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
The Christ Hospital
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: E. Steve Woodle, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: E. Steve Woodle, MD, FACP, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00908583     History of Changes
Other Study ID Numbers: X05295
Study First Received: May 26, 2009
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013