Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin

Maimónides Biomedical Research Institute of Córdoba150 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Renal Transplant Infection

Interventions

ThymoglobulinDRUG

This study will use non-probability, convenience sampling from patients kidney transplants who receive induction immunosuppressive therapy with thymoglobulin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Renal transplant recipients with CMV-positive serology. 2. Patients with pre-transplant, CMV-specific CD8+ T cell-mediated immunity, i.e. IFNγ levels ≥0.2 UI/mL (QF-CMV Reactive). 3. Adults over 18 years of age. 4. Patients receiving induction therapy with thymoglobulin (at least a cumulative dosage of 1mg/kg). 5. Patients receiving prophylaxis with valganciclovir (900 mg/day, adjusted to kidney function) until day 90 after transplant. 6. Patients who signed an informed consent Exclusion Criteria: 1. Multivisceral transplantation, including pancreas-kidney transplantation. 2. HIV infected patients. 3. Patients who cannot comply with the monitoring protocol.

Locations (1)

Hosìtal Universitario Reina Sofia

Córdoba, Spain

Outcomes

Primary Outcomes

CMV-specific, CD8+ T-cell immunity

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).

Time frame: 18 months

Data from ClinicalTrials.gov

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