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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Patient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy
University of Chicago
Chicago, Illinois, United States
Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA).
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
Strong Human Leukocyte Antigen (HLA) antibodies with mean fluorescence intensity (MFI) reduced by more than 50%
A number of strong HLA antibodies with MFI reduced by more than 50% will be counted
Time frame: 1 year
Time to transplant
Time from the beginning of the implementation of the therapy to kidney transplantation will be measured
Time frame: 1 year
Episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR)
Number of episodes of AMR and ACR after kidney transplantation will be counted
Time frame: 1 year
Death
The incidence of episodes of patient death will be calculated
Time frame: 1 year
Serious infection requiring inpatient intravenous therapies
Incidence rate of the episodes of serious infection requiring inpatient intravenous therapies will be calculated during the study
Time frame: 1 year
Post-transplant lymphoproliferative disorder
The incidence rate of the episodes of post-transplant lymphoproliferative disorder will be calculated
Time frame: 1 year
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