The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body.
The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body. We will look for these cells using a number of laboratory tests; It will require the subjects to each give 65mL of blood at each of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to participate in phase 2 depending on lab results. In phase 2, subjects will be randomized to one of the three following groups: Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group) Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be continued at the same dosage. Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued at the same dosage. There will be an analysis of these cells at different time point, pre and post kidney transplant. The data collection will allow us to study the stability over time of particular phenotypes (cell structures) and T cell function. We will also evaluate how the two different "minimizing protocols" effect the cell structure. Results from laboratory testing may allow us to define certain criteria that can be broadly applied in solid organ transplant recipients. This may allow for safe reduction of the anti-rejection medication that transplant recipients receive.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care.
Northwestern Memorial Hospital
Chicago, Illinois, United States
The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.
Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months \& 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells \& NK cells, naive \& memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). Unfortunately blood samples were lost due to malfunction of liquid nitrogen tank that stopped working during a power loss.
Time frame: Pre-transplant, 6months & 12 months post-transplant
Donor Specific Hypo-reactivity.
Identify, by studying recipients for development of donor specific hypo-reactivity and through immunopathologic analysis of renal allograft biopsies, immunologically stable renal transplant patients in whom immunosuppression can be safely minimized. Unfortunately this secondary outcome was not studied because of lost samples that did not allowed us further analysis to identify patients with donor specific hypo reactivity.
Time frame: Pre-transplant, 6mo & 12mo post-transplant
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