- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
recipients aged 20-40
CMV viral load
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recipients older than 60
CMV viral load
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What is the study measuring?
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
Time Frame: 1 year
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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
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1 year
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CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy
Time Frame: 1 year
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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
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1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander Maskin, MD, University of Nebraska
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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