Study of CMV in Kidney Transplant Recipients

October 15, 2024 updated by: University of Nebraska

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Recipients of renal transplants at the University of Nebraska Medical Center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
recipients aged 20-40
CMV viral load
Other: CMV viral load
recipients older than 60
CMV viral load
Other: CMV viral load

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexander Maskin, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0742-13-EP

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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