NCT02061215

Study of CMV in Kidney Transplant Recipients

Effects of Age on Immune Risk Profile in CMV Seropositive Kidney Transplant Recipients After Release From CMV Prophylaxis

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• CMV Viral Loads in Seropositive Renal Transplant Recipients

Interventions

Type	Name	Description
OTHER	CMV viral load

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-07-14
• Completion: 2015-07-14
• First posted: 2014-02-12
• Last updated: 2024-10-17

Locations

1 site across 1 country: United States