Study of CMV in Kidney Transplant Recipients

CMV Viral Loads in Seropositive Renal Transplant Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02061215
• Other study ID #: 0742-13-EP
• Status: Withdrawn
• Start date: April 2014
• Est. completion date: July 14, 2015

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 14, 2015
• Est. primary completion date: July 14, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• CMV Viral Loads in Seropositive Renal Transplant Recipients

Intervention

Other:
• CMV viral load

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy	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
Primary	CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy	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