Clinical trial NCT02630537: Validation of Lophius Kits T-Track® CMV and T-Track® EBV in Hemodialysis Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure Chronic Requiring Dialysis
Keywords: Cytomegalovirus
Epstein- Barr virus
Cell-mediated immunity
T-Track® CMV
T-Track® EBV
hemodialysis
ELISpot
Lead sponsor: Lophius Biosciences GmbH
Sponsor class: INDUSTRY
First posted: 2015-12-15
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient being hemodialysis-dependent due to end-stage kidney disease

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
measure: 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
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Regensburg
name: Bernhard Banas, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banas B, Boger CA, Luckhoff G, Kruger B, Barabas S, Batzilla J, Schemmerer M, Kostler J, Bendfeldt H, Rascle A, Wagner R, Deml L, Leicht J, Kramer BK. Validation of T-Track(R) CMV to assess the functionality of cytomegalovirus-reactive cell-mediated immunity in hemodialysis patients. BMC Immunol. 2017 Mar 7;18(1):15. doi: 10.1186/s12865-017-0194-z.