Status:
COMPLETED
Desensitization in Kidney Transplantation
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
HLA Sensitization
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To determine if deletional strategies will provide effective desensitization.
Detailed Description
A prospective iterative trial of proteasome inhibitor (PI)-based therapy for reducing HLAantibody (Ab) levels was conducted in five phases differing in bortezomib dosing density and plasmapheresis tim...
Eligibility Criteria
Inclusion
- Age between 18 and 65
- Voluntary written informed consent
- Patient on deceased donor wait list with a current or peak cytotoxic or calculated panel reactive antibody (PRA) \> 20%
Exclusion
- Myocardial infarction within 6 months
- Patient received investigational drug within 14 days prior to initiation of study treatment
- Serious medical or psychological illness
- Diagnosed with malignancy within three years, except complete research of basal cell carcinoma or squamous cell carcinoma of skin, an insitu malignancy or low risk prostate cancer after curative therapy
- Absolute neutrophil count (ANC) \< 1000
- Receipt of live vaccine within 4 weeks of study entry
- Female subject that is breast feeding
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00908583
Start Date
May 1 2009
End Date
November 1 2012
Last Update
April 1 2016
Active Locations (2)
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1
The Christ Hospital
Cincinnati, Ohio, United States, 45267
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267