University of Chicago
Chicago, Illinois, 60637, United States
NCT Number: NCT05345717
This proposal's objective is to determine whether belatacept, in conjunction with a proteasome inhibitor can be used to safely increase the likelihood of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1 / Phase 2
Chicago, Illinois, 60637, United States
This is a pilot study to test the safety and effectiveness of the desensitization therapy with belatacept and proteasome inhibitor to increase the likelihood of of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy
Other names: proteasome inhibitor
Time frame: 1 year
The likelihood of finding a suitable donor will calculated base on calculated Panel of Reactive Antibodies measured 1month after the therapy
Time frame: 1 year
A number of strong HLA antibodies with MFI reduced by more than 50% will be counted
Time frame: 1 year
Time from the beginning of the implementation of the therapy to kidney transplantation will be measured
Time frame: 1 year
Number of episodes of AMR and ACR after kidney transplantation will be counted
Time frame: 1 year
The incidence of episodes of patient death will be calculated
Time frame: 1 year
Incidence rate of the episodes of serious infection requiring inpatient intravenous therapies will be calculated during the study
Time frame: 1 year
The incidence rate of the episodes of post-transplant lymphoproliferative disorder will be calculated
University of Chicago
Other
Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.
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