Study of CMV in Kidney Transplant Recipients

University of Nebraska

Status: Terminated

Conditions: CMV Viral Loads in Seropositive Renal Transplant Recipients

Treatments: Other: CMV viral load

Study type: Observational

Funder types: Other

Identifiers

NCT02061215

0742-13-EP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

7 participants in 2 patient groups

recipients aged 20-40

Description:

CMV viral load

Treatment:

Other: CMV viral load

recipients older than 60

Description:

CMV viral load

Treatment:

Other: CMV viral load