Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Kidney Transplant Recipients

NCT02083042 | Completed DMC

• 1 other identifier: LB-A2(Urea-CMV)
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a protective cut-off value for CMV reactivations/disease in kidney transplant recipients. Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.

Conditions

Cytomegalovirus; Kidney Transplantation; CMV Specific Immune Response

Keywords

CMV; T-Track CMV; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Determination of changes in pp65 and/or IE-1 specific CMI applying T-Track® CMV

  before Tx, week 3,6,9,12,15,18 and 21 after Tx and unscheduled visits in case of suspicion of CMV related complications; individual observation period 6 months

Secondary Outcomes (1)

• Changes in CMV viral load measured by CMV-PCR or pp65 antigenemia test

  week 3,6,9,12,15,18,21 after Tx and in case of CMV complications

Other Outcomes (1)

• opportunistic infections, graft damage/rejection/loss,

  6 months after Tx

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients of intermediate risk groups for CMV serostatus (D+/R+; D-/R+), and scheduled for the preemptive antiviral strategy

You may qualify if:

• Patient receiving a kidney graft
• 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+,)
• Patient scheduled to follow the preemptive antiviral strategy with oral valganciclovir or intravenous ganciclovir after transplantation
• 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
• Male or female patient at least 18 years of age
• Written informed consent

You may not qualify if:

• 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)
• Patient receiving ATG as induction therapy
• 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 before transplantation that could interfere with the study objectives
• Patient is unable to comply with the visit schedule in the protocol
• Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator

Sponsors & Collaborators

• Lophius Biosciences GmbH: lead

Study Sites (1)

Lophius Biosciences GmbH

Regensburg, 93053, Germany

Location

Related Publications (1)

• Banas B, Steubl D, Renders L, Chittka D, Banas MC, Wekerle T, Koch M, Witzke O, Muhlfeld A, Sommerer C, Habicht A, Hugo C, Hunig T, Lindemann M, Schmidt T, Rascle A, Barabas S, Deml L, Wagner R, Kramer BK, Kruger B. Clinical validation of a novel enzyme-linked immunosorbent spot assay-based in vitro diagnostic assay to monitor cytomegalovirus-specific cell-mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study. Transpl Int. 2018 Apr;31(4):436-450. doi: 10.1111/tri.13110. Epub 2018 Jan 16.

  PMID: 29284181 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2014
• First Posted: March 11, 2014
• Study Start: August 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

DE (1)