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IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION

NCT06635525•Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (3)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

ASST Santi Paolo e Carlo

Milan, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

Key Dates

Start Date

October 1, 2024

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

October 10, 2024

Enrollment

146

ESTIMATED participants

Conditions

Chronic Kidney Disease Requiring Chronic DialysisVaccine Response

Interventions

Influenza vaccination

BIOLOGICAL

SARS-CoV-2 vaccine

BIOLOGICAL

Contacts

Manuel A Podesta', MD, PhD

CONTACT

0039 0255034568 manuel.podesta@policlinico.mi.it

Giuseppe Castellano, MD, PhD

CONTACT

giuseppe.castellano@policlinico.mi.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION

Inclusion Criteria

Exclusion Criteria

Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients

Fluid Intake After Hemodialysis

Lumasiran in Hyperoxalaemic Patients on Haemodialysis

Evaluation of Routinely Measured Patient-reported Outcomes in Hemodialysis Care

COVID19 Vaccine in SOT Adult Recipients

Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.