Study of CMV in Kidney Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-07-14

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.

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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.

Conditions

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CMV Viral Loads in Seropositive Renal Transplant Recipients

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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recipients aged 20-40

CMV viral load

Intervention Type OTHER

recipients older than 60

CMV viral load

Intervention Type OTHER

Interventions

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CMV viral load

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adults young age 20-40 years and old \>/= 60 years
2. Anticipate renal transplant within 2 weeks
3. CMV sero-positive renal transplant recipients
4. HLA type of A1, A2, B7 of recipient

Exclusion Criteria

1. Pediatric recipients
2. Multi-organ transplant recipients
3. Highly sensitized (antigen level) recipients
4. Prior organ transplant recipients
5. Patients who do not wish to participate in study, or who cannot consent to research
6. Patients with active CMV infection
7. Seronegative
8. HLA Type of organ recipient not corresponding to A1,A2, B7

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes