Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Kidney Transplant Recipients (CMValue)
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|ClinicalTrials.gov Identifier: NCT02083042|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 8, 2016
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.
|Condition or disease|
|Cytomegalovirus Kidney Transplantation CMV Specific Immune Response|
|Study Type :||Observational|
|Actual Enrollment :||97 participants|
|Official Title:||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|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||December 2015|
- Determination of changes in pp65 and/or IE-1 specific CMI applying T-Track® CMV [ Time Frame: 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 ]
- Changes in CMV viral load measured by CMV-PCR or pp65 antigenemia test [ Time Frame: week 3,6,9,12,15,18,21 after Tx and in case of CMV complications ]
- opportunistic infections, graft damage/rejection/loss, [ Time Frame: 6 months after Tx ]
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): NCT02083042
|Lophius Biosciences GmbH|
|Regensburg, Germany, 93053|