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

Renal Transplant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147183
• Other study ID #: FIB-TIM-2015-01
• Status: Completed
• Start date: August 9, 2016
• Est. completion date: October 21, 2019

Study information

• Verified date: July 2021
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 21, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Renal transplant recipients with CMV-positive serology.

2. Patients with pre-transplant, CMV-specific CD8+ T cell-mediated immunity, i.e. IFN? 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.

Related Conditions & MeSH terms

• Renal Transplant Infection

Intervention

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

Locations

Country	Name	City	State
Spain	Hosìtal Universitario Reina Sofia	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 IFN? =0.2 UI/mL (QF-CMV Reactive).	18 months