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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03147183
Enrollment
150
Registered
2017-05-10
Start date
2016-08-09
Completion date
2019-10-21
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant Infection

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).

Interventions

DRUGThymoglobulin

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

Sponsors

Maimónides Biomedical Research Institute of Córdoba
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CMV-specific, CD8+ T-cell immunity18 monthsPercentage 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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026