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

NCT02083042 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 97

Last updated 2016-02-08

No results posted yet for this study

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

Sponsors & Collaborators

  • Lophius Biosciences GmbH

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02083042 on ClinicalTrials.gov