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CompletedNCT03147183Updated Jul 20, 2021

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

An observational study in Renal Transplant Infection, sponsored by Maimónides Biomedical Research Institute of Córdoba. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Maimónides Biomedical Research Institute of Córdoba · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Renal Transplant Infection
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In context

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are candidates for renal transplant and who fulfil the clinical criteria established by the participating institutions to receive induction immunosuppressive therapy. Participating institutions may include centers from the Spanish Network for Research in Infectious Diseases (REIPI, Transplantation Program) as well as other centers outside the network.

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

Exclusion Criteria:

  1. Multivisceral transplantation, including pancreas-kidney transplantation.
  2. HIV infected patients.
  3. Patients who cannot comply with the monitoring protocol.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • candidates for renal transplant

    Drug: Thymoglobulin

Interventions

  • DrugThymoglobulin

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

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Hosìtal Universitario Reina Sofia
    Córdoba, 14004, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03147183
Lead sponsor
Maimónides Biomedical Research Institute of Córdoba
Responsible party
Sponsor
First posted
May 10, 2017
Start date
Aug 9, 2016
Primary completion
Oct 31, 2018
Completion
Oct 21, 2019
Last update
Jul 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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