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

• Sponsor: Maimónides Biomedical Research Institute of Córdoba (Other)
• Overall Status: Completed
• CT.gov ID: NCT03147183
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Actual Duration (Months): 38.4
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant Infection	Drug: Thymoglobulin

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin
• Actual Study Start Date: Aug 9, 2016
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Oct 21, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hosìtal Universitario Reina Sofia	Córdoba		Spain	14004

Sponsors and Collaborators

• Maimónides Biomedical Research Institute of Córdoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maimónides Biomedical Research Institute of Córdoba
• ClinicalTrials.gov Identifier: NCT03147183
• Other Study ID Numbers: FIB-TIM-2015-01
• First Posted: May 10, 2017
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Thymoglobulin

Study Results

No Results Posted as of Jul 20, 2021