Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02083042
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2014-02-23
Brief Title:
Clinical Validation of Lophius Biosciences Kit T-Track CMV in Kidney Transplant Recipients
Sponsor:
Lophius Biosciences GmbH
Organization:
Lophius Biosciences GmbH
Study Overview
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 ReactivationsDisease in Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMValue
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 reactivationsdisease 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
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
Detailed Description:
Severe clinical complications including acute rejection and opportunistic infections in solid organ transplantation SOT are mainly caused by inadequate impairment of cell-mediated immunity CMI by immunosuppressive therapy In particular CMV is responsible for increased morbidity and mortality revealing the need for either prophylactic or preemptive antiviral treatment Recipients with negative CMV serology R- receiving a graft from a seropositive donor D are at highest risk of developing CMV-associated complications Therefore these patients usually receive antiviral prophylaxis whereas patients at intermediate risk DR or D-R are treated either prophylactically or preemptively Although prophylaxis is efficient it is also accompanied by harmful side effects and high costs Thus there is a need for a personalized antiviral as well as immunosuppressive therapy to optimally treat the patient and to improve long-term patient and graft survival The detection of a protective threshold of functional CMV-reactive cells may help to predict the onset of viral complications thereby minimizing harmful side effects Currently available tools to measure CMV-specific cellular immunity reveal striking limitations including a lack of standardization necessitating a commercially available standardized test system The 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 This study aims to assess the suitability of the Lophius Biosciences kit T-Track CMV to determine the CMV-specific CMI in renal transplant recipients scheduled for a preemptive antiviral treatment strategy Furthermore it will be investigated if the results obtained with T-Track CMV are suitable to define a cut-off value of CMV-specific CMI mediating protection from CMV reactivations and related complications Moreover possible associations between CMV-specific CMI measured with T-Track CMV and clinical complications including acute rejection episodes and opportunistic infections will be analyzed as well as the influence of the immunosuppressive treatment and the patients HLA type on viral immunity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None