An observational study in Coronavirus Disease 2019 Vaccines and Renal Dialysis, sponsored by Hospital Italiano de Buenos Aires. Completed at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Hospital Italiano de Buenos Aires · Observational
It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy. Objectives: To evaluate the safety and efficacy of Coronavirus disease 2019 vaccines in hemodialysis patients.
Given the vulnerability of people with chronic kidney disease to Coronavirus 2019 , leading nephrology societies such as the National Kidney Federation and the American Kidney Foundation have issued statements calling for prioritization of these patients for vaccination. It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy.
Objectives:
Methods Design: Multicenter, observational and analytical study of a prospective cohort of hemodialysis patients 18 years and older who received immunization with a Coronavirus disease 2019 vaccine in the Autonomous City of Buenos Aires in a vaccination plan.
Analysis The proportion of patients with Adverse events presumably attributable to vaccination and immunization will be estimated with its 95% confidence interval. The immunoglobulin G titer for coronavirus type 2 causing severe acute respiratory syndrome will be compared using Generalized Estimating Equations models.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 950 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Hospital Italiano de Buenos Aires is the lead sponsor of 128 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hemodialysis patients in an immunization plan with a COVID-19 vaccine from the hemodialysis centers of the Autonomous City of Buenos Aires
Exclusion Criteria:
Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine
Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine
Time frame: one year
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization
Time frame: one year
Plan to share: Undecided
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Italiano de Buenos Aires