Study of CMV in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

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

Conditions
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CMV Viral Loads in Seropositive Renal Transplant Recipients

Intervention / Treatment
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* Other: CMV viral load


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| recipients aged 20-40<br>CMV viral load | Other: CMV viral load<br> <br> |
| recipients older than 60<br>CMV viral load | Other: CMV viral load<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CYTOF, CMV, PCR, HLA