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PI halted study
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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.
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:
In addition, clinical data will be collected at the time points indicated,particularly renal function and the presence/absence of acute rejection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recipients aged 20-40 | CMV viral load |
| |
| recipients older than 60 | CMV viral load |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV viral load | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy | 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 | 1 year |
| CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy | 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Recipients of renal transplants at the University of Nebraska Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Maskin, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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blood samples