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Study of CMV in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02061215
Recruitment Status : Withdrawn
First Posted : February 12, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Alexander Maskin, 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 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.


Condition or disease Intervention/treatment
CMV Viral Loads in Seropositive Renal Transplant Recipients Other: CMV viral load

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Age on Immune Risk Profile in CMV Seropositive Kidney Transplant Recipients After Release From CMV Prophylaxis
Study Start Date : April 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
recipients aged 20-40
CMV viral load
Other: CMV viral load
recipients older than 60
CMV viral load
Other: CMV viral load



Primary Outcome Measures :
  1. 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 [ Time Frame: 1 year ]
  2. 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 [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Recipients of renal transplants at the University of Nebraska Medical Center
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061215


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska

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Responsible Party: Alexander Maskin, Assistant Professor of Surgery, University of Nebraska
ClinicalTrials.gov Identifier: NCT02061215     History of Changes
Other Study ID Numbers: 742-13-EP
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by Alexander Maskin, University of Nebraska:
CYTOF
CMV
PCR
HLA