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OpenTrials
Completed

NCT Number: NCT03147183

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

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).

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Key information

Conditions

Renal Transplant Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hosìtal Universitario Reina Sofia

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thymoglobulin

Drug

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

Primary outcomes

  1. CMV-specific, CD8+ T-cell immunity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 10, 2017
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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