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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
Sponsor:
Information provided by (Responsible Party):
Lophius Biosciences GmbH

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient being hemodialysis-dependent due to end-stage kidney disease
Criteria

Inclusion Criteria:

  • Patient being hemodialysis-dependent due to end-stage kidney disease
  • Male or female patient at least 18 years of age
  • Written informed consent

Exclusion Criteria:

  • Patient requires ongoing dosing with a systemic immunosuppressive drug
  • Patient has received immunosuppressive therapy within the last three month
  • Patient is known to be positive for HIV or suffering from chronic hepatitis infections
  • Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives
  • Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator

Information from the National Library of Medicine

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


Sponsors and Collaborators
Lophius Biosciences GmbH
Investigators
Principal Investigator: Bernhard Banas, Prof. University Medical Center Regensburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lophius Biosciences GmbH
ClinicalTrials.gov Identifier: NCT02630537     History of Changes
Other Study ID Numbers: LB-A1 (UREA-CMV-EBV)
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Lophius Biosciences GmbH:
Cytomegalovirus
Epstein- Barr virus
Cell-mediated immunity
T-Track® CMV
T-Track® EBV
hemodialysis
ELISpot

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic