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).

Study Overview

• Status: Completed
• Conditions: Renal Transplant Infection
• Intervention / Treatment: Drug: Thymoglobulin

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hosìtal Universitario Reina Sofia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
candidates for renal transplant	Drug: Thymoglobulin; This study will use non-probability, convenience sampling from patients kidney transplants who receive induction immunosuppressive therapy with thymoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	18 months

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2016
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Thymoglobulin
• Other Study ID Numbers: FIB-TIM-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No