Clinical validation of Lophius Biosciences Kit T-Track® CMV to assess the functionality of CMV-specific cell-mediated immunity (CMI) and its suitability to determine a protective cut-off value for CMV reactivations/disease in kidney transplant recipients

• Conditions: B25; Z94.0; Cytomegaloviral disease; Kidney transplant status

• Registration Number: DRKS00007107
• Lead Sponsor: ophius Biosciences gmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-12
• Study Completion: 2015-10-28
• Results First Posted: 2018-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

I. Patient receiving a kidney graft

II. Recipient being CMV-seropositive prior transplantation and receiving a graft from either a CMV-seropositive or from a seronegative donor (intermediate risk groups, D+/R+; D-/R+)

III. Patient scheduled to follow the preemptive antiviral strategy with oral valganciclovir or intravenous ganciclovir after transplantation

VI. Patient receiving the standard triple immunosuppressive regimen (CNI, MMF/MPA or mTOR inhibitors, steroids), with or without induction therapy (except ATG) as start therapy after transplantation

V. Male or female patient at least 18 years of age

VI. Written informed consent

Exclusion Criteria

I. Patient is scheduled for the optional visit 1, but requires ongoing treatment with a systemic immunosuppressive drug already prior to kidney transplantation (except induction therapy other than ATG)

II. Patient receiving ATG as induction therapy

III. Patient is known to be positive for HIV or suffering from chronic hepatitis infections

IV. Patient has significant uncontrolled concomitant infections or other unstable medical conditions before transplantation that could interfere with the study objectives

V. Patient is unable to comply with the visit schedule in the protocol

VI. Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the number of CMV-seropositive transplant recipients (as defined by serostatus pre Tx) showing positive T-Track® CMV test results prior to the start of immunosuppressive therapy (clinical sensitivity, visit 1) and during immunosuppressive therapy (clinical sensitivities each at visit 2 - visit 8).