Clinical trial NCT02061215: Study of CMV in Kidney Transplant Recipients
Official title: Effects of Age on Immune Risk Profile in CMV Seropositive Kidney Transplant Recipients After Release From CMV Prophylaxis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: CMV Viral Loads in Seropositive Renal Transplant Recipients
Keywords: CYTOF
CMV
PCR
HLA
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recipients of renal transplants at the University of Nebraska Medical Center

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 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: 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.

Eligibility 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

Primary outcomes:
measure: CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy
timeFrame: 1 year
measure: CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Alexander Maskin, MD
role: PRINCIPAL_INVESTIGATOR
References: