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Clinical Trial Summary

Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. In addition, clinical data will be collected at the time points indicated, particularly renal function and the presence/absence of acute rejection.


Clinical Trial Description

Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are CMV seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. Blood from 10 patients in each age group will be studied, to collect virologic and immune response data: - CYTOF (broad array of measurements) - Tetramer assays (requires recipient HLA type of A1, A2, B7) - CMV viral load PCR - Response to pneumococcal antigens and inactivated influenza virus In addition, clinical data will be collected at the time points indicated,particularly renal function and the presence/absence of acute rejection. ;


Study Design


Related Conditions & MeSH terms

  • CMV Viral Loads in Seropositive Renal Transplant Recipients

NCT number NCT02061215
Study type Observational
Source University of Nebraska
Contact
Status Withdrawn
Phase
Start date April 2014
Completion date July 14, 2015