Validation of Lophius Kits T-Track® CMV and T-Track® EBV in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT02630537|
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection of transplanted organs. Thus, in transplant recipients a life-long and individualized immunosuppressive medication is required to avoid graft rejection. However, a too weak suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas a too potent suppression of CMI supports opportunistic infections and reactivation of persistent viruses.
One of the biggest challenges in the field of transplantation is to provide a personalized immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI. This could lead to a reduction of graft rejections and virus reactivations in transplant recipients.
With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH has implemented its novel proprietary T-activation technology for an improved assessment of the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open up the opportunity to characterize the functionality of CMI as an entire network.
The planned clinical multicenter study aims to verify the suitability of the two assays for a reliable assessment of the functionality of CMI.
Hemodialysis patients have been identified as an appropriate patient cohort for investigating the clinical sensitivity of the Lophius assays as these patients closely resemble kidney transplant recipients prior to an immunosuppressive therapy.
The determination of the functional CMI in the course of an immunosuppressive treatment may in future enable physicians to optimize the individual immunosuppressive and antiviral therapy in transplant recipients to reduce the risk of rejection as well as virus reactivations and associated diseases.
|Condition or disease|
|Renal Failure Chronic Requiring Dialysis|
|Study Type :||Observational|
|Actual Enrollment :||133 participants|
|Official Title:||Clinical Validation of Lophius Kits T-Track® CMV and T-Track® EBV to Assess the Functionality of Cell-mediated Immunity (CMI) in Hemodialysis Patients|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
- Percentage of CMV or EBV seropositive hemodialysis patients showing significant numbers of functional CMV or EBV-protein-reactive blood leucocytes applying T-Track® CMV or T-Track® EBV [ Time Frame: 1 day ]Determination of the clinical sensitivity of T-Track® CMV and T-Track® EBV. T-Track® assays are based on the stimulation of peripheral blood mononuclear cells (PBMC) with preselected immunodominant T-activated proteins derived from the human Cytomegalovirus (CMV) and the Epstein-Barr-Virus (EBV) and the subsequent quantification of IFN-gamma producing blood leucocytes (Lophius biomarker for assessing the functionality of CMI) applying ELISpot technology.
- Percentage of CMV or EBV seropositive hemodialysis patients showing significant numbers of functional CMV or EBV-protein-reactive blood leucocytes applying EBV and CMV peptide-loaded Pro5® Pentamers and the Quantiferon® CMV assay [ Time Frame: 1 day ]The comparison of the suitability of T-Track® CMV and T-Track® EBV to EBV and CMV peptide-loaded Pro5® Pentamers and the Quantiferon® CMV assay (commercially available competing products)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630537
|Principal Investigator:||Bernhard Banas, Prof.||University Medical Center Regensburg|