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

NCT03147183 | Completed FDA Drug

• 1 other identifier: FIB-TIM-2015-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Transplant Infection

Outcome Measures

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).

  18 months

Study Arms (1)

candidates for renal transplant

Drug: Thymoglobulin

Interventions

Thymoglobulin DRUG

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

candidates for renal transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Multivisceral transplantation, including pancreas-kidney transplantation.
• HIV infected patients.
• Patients who cannot comply with the monitoring protocol.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hosìtal Universitario Reina Sofia

Córdoba, 14004, Spain

Location

MeSH Terms

Interventions

thymoglobulin

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: August 9, 2016
• Primary Completion: October 31, 2018
• Study Completion: October 21, 2019
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)