Study of CMV in Kidney Transplant Recipients
- Conditions
- CMV Viral Loads in Seropositive Renal Transplant Recipients
- Interventions
- Other: CMV viral load
- Registration Number
- NCT02061215
- Lead Sponsor
- University of Nebraska
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- Adults young age 20-40 years and old >/= 60 years
- Anticipate renal transplant within 2 weeks
- CMV sero-positive renal transplant recipients
- HLA type of A1, A2, B7 of recipient
- Pediatric recipients
- Multi-organ transplant recipients
- Highly sensitized (antigen level) recipients
- Prior organ transplant recipients
- Patients who do not wish to participate in study, or who cannot consent to research
- Patients with active CMV infection
- Seronegative
- HLA Type of organ recipient not corresponding to A1,A2, B7
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description recipients aged 20-40 CMV viral load CMV viral load recipients older than 60 CMV viral load CMV viral load
- Primary Outcome Measures
Name Time Method CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy 1 year CMV viral loads in younger (age 20-40) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy 1 year CMV viral loads in older (age \>/= 60) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States