Name (Synonyms) | Correlation | |
---|---|---|
drug3263 | everolimus Wiki | 0.71 |
drug2705 | Standard of Care Triple IS Wiki | 0.71 |
drug3325 | lulizumab pegol Wiki | 0.71 |
drug3341 | methylprednisolone Wiki | 0.71 |
drug1225 | Health Care Worker Survey Wiki | 0.71 |
drug3195 | belatacept Wiki | 0.71 |
drug3358 | mycophenolic acid Wiki | 0.71 |
drug3181 | antithymocyte globulin (rabbit) Wiki | 0.71 |
drug3356 | mycophenolate mofetil Wiki | 0.71 |
drug1559 | Lenzilumab Wiki | 0.71 |
drug548 | COVID-19 Serology Wiki | 0.50 |
drug2219 | Prednisone Wiki | 0.32 |
drug2698 | Standard of Care Wiki | 0.13 |
drug2122 | Placebo Wiki | 0.04 |
There are 2 clinical trials
The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.
Description: This outcome is defined by a composite 1 year post-transplant endpoint of: detection of de novo donor-specific antibodies (dnDSA) (Core Laboratory), acute cellular rejection (ACR) ≥ ISHLT 2R rejection (Core Laboratory), antibody mediated rejection (AMR) ≥ ISHLT AMR 1 (Core Laboratory), hemodynamic compromise rejection in the absence of a biopsy or histological rejection, death, or re-transplantation.
Measure: Proportion of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation - By Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: A comparison by treatment group of the incidence of freedom from development of de novo donor-specific antibodies (dnDSA). dnDSA is a newly developed alloantibody that is against the donor organ.
Measure: Freedom of Detection of de Novo Donor-Specific Antibodies (dnDSA) - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: A comparison by treatment group of the incidence of freedom from development of acute cellular rejection ≥2R (Reference: International Society of Heart and Lung Transplantation [ISHLT] acute cellular rejection-grade 2R or greater severity).
Measure: Freedom from Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Rejection - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: A comparison by treatment group of the incidence of freedom from development of antibody-mediated rejection defined as ISHLT grade AMR 1 or greater severity.
Measure: Freedom from Antibody Mediated Rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1 - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: A comparison by treatment group of the incidence of freedom from development of hemodynamic compromise (HDC). Hemodynamic compromise is defined by: - Need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m^2 or a 25% decrease from baseline, in addition to one of the following: ejection fraction of <40% or a 20% decrease from baseline, and the need for inotropic agents OR fractional shortening of <20% or a 25% decrease from baseline, and the need for inotropic agents.
Measure: Freedom from Hemodynamic Compromise Rejection in the Absence of a Biopsy or Histological Rejection - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: A comparison by treatment group of the incidence of freedom from development of episode of rejection requiring treatment. Reference: Acute cellular rejection as defined by the 2004 International Society of Heart and Lung Transplantation (ISHLT) grading scale.
Measure: Freedom from Any-Treated Rejection - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: A comparison by treatment group of the incidence of freedom from acute cellular rejection (ACR) ≥ ISHLT 2R rejection. Reference: 2004 International Society of Heart and Lung Transplantation [ISHLT [ grading scale).
Measure: Freedom from Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Per Patient - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: Time from transplant, free of antibody mediated rejection, defined as ISHLT grade AMR 1 or greater will be compared between the treatment groups. Hemodynamic compromise is defined as the need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m2 or a 25% decrease from baseline in addition to one of the following: Ejection fraction of <40% or a 20% decrease from baseline, and the need for inotropic agents Fractional shortening of <20% or a 25% decrease from baseline, and the need for inotropic agents
Measure: Freedom from Antibody Mediated Rejection (AMR) (≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1) Per Participant - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)]Description: Time from transplant, free of antibody mediated rejection, defined as ISHLT grade AMR 1 or greater will be compared between the treatment groups
Measure: Freedom from Hemodynamic Compromise Rejection in the Absence of a Biopsy or Histological Rejection Per Participant - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: Incidence of all-cause mortality will be compared between the treatment groups.
Measure: Occurrence of Death - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: Incidence of participant(s) being re-listed for transplant will be compared between the treatment groups.
Measure: Occurrence of Re-Listed for Transplantation - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)Description: Incidence of participant(s) re-transplantation will be compared between the treatment groups.
Measure: Occurrence of Re-Transplantation - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)]Description: The frequency of events will be compared between the treatment groups.
Measure: Number of Acute Cellular Rejection (≥ International Society of Heart and Lung Transplantation (ISHLT) 2R) Per Patient - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)]Description: The frequency of events will be compared between the treatment groups.
Measure: Number of Antibody Mediated Rejection (AMR) (≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1) Per Participant - by Treatment Group Time: 12 months post-transplantationDescription: The frequency of events will be compared between the treatment groups.
Measure: Number of Rejection Episodes Associated with Hemodynamic Compromise (HDC) Per Participant - by Treatment Group Time: From transplant through 12 months post transplant surgery (12 months)]Description: Per protocol, per clinical research site standard of care.
Measure: Change in Intravascular Ultrasound (IVUS) Measurements From Baseline to 1 Year Post-Transplant- by Treatment Group Time: Baseline (4 to 8 weeks post-transplant), 1 year post-transplantDescription: In accordance with the International Society of Heart and Lung Transplantation (ISHLT) Cardiac Allograft Vasculopathy (CAV) angiographic grading scale.
Measure: Angiographic Evidence of Cardiac Allograft Vasculopathy (CAV) - by Treatment Group Time: 12 months post-transplantationDescription: Incidence of participant loss to follow up will be compared between the treatment groups.
Measure: Participant Loss to follow up - by Treatment Group Time: 12 months post-transplantationDescription: The frequency of serious infections requiring intravenous antimicrobial therapy and need for hospitalization will be compared between treatment groups.
Measure: Occurrence of Serious Infections Requiring Intravenous Antimicrobial Therapy and Need for Hospitalization - by Treatment Group Time: Through 24 months post transplant surgeryDescription: The incidence of tuberculosis will be compared between treatment groups.
Measure: Incidence of Tuberculosis - by Treatment Group Time: Through 24 months post transplant surgeryDescription: The incidence of CMV infection will be compared between treatment groups.
Measure: Incidence of Cytomegalovirus (CMV) Infection - by Treatment Group Time: Through 24 months post transplant surgeryDescription: The incidence of PTLD will be compared between treatment groups.
Measure: Incidence of Post-Transplant Lymphoproliferative Disease (PTLD) - by Treatment Group Time: Through 24 months post transplant surgeryDescription: The number of participants who discontinue study drug, per protocol, will be compared between treatment groups.
Measure: Tolerability (Discontinuation of Study Drug) of Tocilizumab (TCZ) - by Treatment Group Time: Through 24 months post transplant surgeryThe purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.
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 transplantationDescription: 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 transplantationDescription: 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 transplantationDescription: 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 transplantationDescription: 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 transplantationDescription: 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