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

Maimónides Biomedical Research Institute of Córdoba

Status: Completed

Conditions: Renal Transplant Infection

Treatments: Drug: Thymoglobulin

Study type: Observational

Funder types: Other

Identifiers

NCT03147183

FIB-TIM-2015-01

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

candidates for renal transplant

Treatment:

Drug: Thymoglobulin