Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination (NCT06635525) | Clinical Trial Compass
RecruitingNot Applicable
Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
Italy146 participantsStarted 2024-10-16
Plain-language summary
The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.
Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.
Participants will:
* Be enrolled at the time of influenza vaccination
* Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination
* Be asked to provide relevant clinical information and a blood sample at each visit
Who can participate
Age range
18 Years – 70 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:
* Age between 18 and 70 years
* Patients undergoing thrice-weekly hemodialysis / peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency
* Subjects eligible to receive a seasonal influenza vaccine
* Signed informed consent for participation in the study
Exclusion Criteria:
* Recent influenza infection (clinically resolved less than 3 months ago).
* Administration of immunosuppressive drugs in the two weeks prior to vaccination.
* Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation).
* Systemic infection clinically resolved less than two weeks before enrollment.
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
Frequency of serological response to influenza vaccination
Timeframe: From enrollment to 30±3 days after vaccination
Trial details
NCT IDNCT06635525
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico