Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving… (NCT03147183) | Clinical Trial Compass
CompletedNot Applicable
Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin
Spain150 participantsStarted 2016-08-09
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CMV-specific, CD8+ T-cell immunity
Timeframe: 18 months
Trial details
NCT IDNCT03147183
SponsorMaimónides Biomedical Research Institute of Córdoba