Correlated Drug Terms (9)

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	Name (Synonyms)	Correlation
drug3031	tocilizumab Wiki	1.00
drug2813	everolimus Wiki	1.00
drug2904	mycophenolate mofetil Wiki	1.00
drug2906	mycophenolic acid Wiki	1.00
drug499	CT-imaging Wiki	1.00
drug2742	antithymocyte globulin (rabbit) Wiki	1.00
drug2755	belatacept Wiki	1.00
drug2890	methylprednisolone Wiki	1.00
drug1898	Prednisone Wiki	0.45

Correlated MeSH Terms (2)

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	Name (Synonyms)	Correlation
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Definitions: Acute T cell Mediated Rejection: Biopsy proven rejection defined by histologic evidence of a Banff grade of ≥1A and clinical treatment for acute rejection. Acute Antibody Mediated Rejection: Diffusely positive immunostaining staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms.

Measure: Proportion of participants who remain free of biopsy-proven acute T-cell mediated or antibody-mediated rejection as defined by Banff criteria

Time: 6 months post transplantation

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Secondary Outcomes

Description: Definitions: Acute T cell Mediated Rejection: Biopsy proven rejection defined by histologic evidence of a Banff grade of ≥1A and clinical treatment for acute rejection. Acute Antibody Mediated Rejection: Diffusely positive immunostaining staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms.

Measure: Proportion of participants who remain free of biopsy-proven acute T-cell mediated or antibody-mediated rejection as defined by Banff criteria

Time: 12 months post transplantation

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Other Outcomes

Description: Mechanistic assay. Evaluation of the frequency of circulating Tregs over time.Exploratory goal: To advance understanding in mechanisms of tolerance.

Measure: EXPLORATORY: Frequency of circulating T Regulatory Cells (Tregs)

Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation

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Description: Mechanistic assay.Donor-specific suppression activity of recipient Tregs will be measured over time by using irradiated donor peripheral blood mononuclear cells (PBMCs) as stimulators. Exploratory goal: To advance understanding in mechanisms of tolerance.

Measure: EXPLORATORY:T Regulatory Cells (Treg) suppressive activity

Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation

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Description: Mechanistic assay that measures the frequency of circulating donor-reactive CD4 conventional T cells, CD8 T cells and Tregs analyzed over time. Exploratory goal: To advance understanding in mechanisms of tolerance.

Measure: EXPLORATORY:Alloreactive T cell frequency

Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation

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Description: Methodology: Analysis of gene expression in peripheral blood mononuclear cells (PBMCs) stimulated with donor antigen presenting cells to explore genes implicated in T cell checkpoint inhibition (CTLA-4, SFASL, NFATC1, NFATC2, LAG3 and HAVCR2, as examples). Exploratory goal: To advance understanding in mechanisms of tolerance.

Measure: EXPLORATORY:Expression of T cell checkpoint inhibition related genes

Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation

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