Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin
- Registration Number
- NCT03147183
- Lead Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Brief Summary
Renal transplant candidates who have CMV-specific, CD8+ T-cells, are CMV-seropositive and carry HLA-A1 and/ or HLA- A2 alleles have a high probability to maintain this type of immunity during the three first months after the transplant, despite induction immunosuppressive therapy (thymoglobulin).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Renal transplant recipients with CMV-positive serology.
- Patients with pre-transplant, CMV-specific CD8+ T cell-mediated immunity, i.e. IFNγ levels ≥0.2 UI/mL (QF-CMV Reactive).
- Adults over 18 years of age.
- Patients receiving induction therapy with thymoglobulin (at least a cumulative dosage of 1mg/kg).
- Patients receiving prophylaxis with valganciclovir (900 mg/day, adjusted to kidney function) until day 90 after transplant.
- Patients who signed an informed consent
Exclusion Criteria
- Multivisceral transplantation, including pancreas-kidney transplantation.
- HIV infected patients.
- Patients who cannot comply with the monitoring protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description candidates for renal transplant Thymoglobulin -
- Primary Outcome Measures
Name Time Method CMV-specific, CD8+ T-cell immunity 18 months Percentage of patients with CMV-specific, CD8+ T-cell immunity at any of the established time points for monitorization. "CMV-specific, CD8+ T-cell immunity" will be defined as production of IFNγ ≥0.2 UI/mL (QF-CMV Reactive).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hosìtal Universitario Reina Sofia
🇪🇸Córdoba, Spain