Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06635525

Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2026-03-30

146

Participants Needed

3

Research Sites

89 weeks

Total Duration

On this page

Sponsors

F

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Lead Sponsor

F

Fondazione Cariplo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Patients undergoing thrice-weekly hemodialysis or peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency
  • Eligible to receive a seasonal influenza vaccine
  • Signed informed consent for participation in the study
Not Eligible

You will not qualify if you...

  • Recent influenza infection clinically resolved less than 3 months ago
  • Use of immunosuppressive drugs in the two weeks before vaccination
  • Received another vaccine in the three weeks before enrollment (except co-administration with study vaccines)
  • Systemic infection clinically resolved less than two weeks before enrollment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

Actively Recruiting

2

ASST Santi Paolo e Carlo

Milan, Italy, 20142

Not Yet Recruiting

3

ASST Fatebenefratelli Sacco

Milan, Italy, 20157

Not Yet Recruiting

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Research Team

M

Manuel A Podesta', MD, PhD

CONTACT

G

Giuseppe Castellano, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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