Renal Failure Chronic Requiring Dialysis Clinical Trial
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
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.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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