Clinical Trials Logo
  1. Home
  2. Renal Dialysis
  3. NCT04944433

Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients

Renal Dialysis Clinical Trial

Official title:
Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients

Clinical Trial Summary

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.

Clinical Trial Description

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: 1. Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine 2. Determine the levels of Immunoglobulin G antibodies in patients who received a Coronavirus disease 2019vaccine between the time before the first dose, at 21 days, at 40 days and at 120 days after immunization. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04944433
Study type Observational
Source Hospital Italiano de Buenos Aires
Contact
Status Completed
Phase
Start date April 9, 2021
Completion date August 4, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT05189795 - The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Completed NCT01125202 - Intervention to Reduce Dietary Sodium in Hemodialysis N/A
Completed NCT00753116 - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension Phase 1
Completed NCT00806130 - Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT05718765 - The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients N/A
Completed NCT03250715 - Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure N/A
Completed NCT05469620 - Adaptive Nutrition Therapy in Hemodialysis N/A
Completed NCT03536858 - Social Networks and Renal Education: Promoting Transplantation N/A
Completed NCT00824837 - Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane Phase 1/Phase 2
Completed NCT03403491 - Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis N/A
Terminated NCT02495662 - The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation Phase 2
Completed NCT01179620 - Certoparin in Renal Patients Undergoing Hemodialysis Phase 3
Completed NCT01017276 - A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis Phase 3
Active, not recruiting NCT04466865 - A Communication Tool to Assist Older Adults Facing Dialysis Choices N/A
Recruiting NCT03782519 - Quality of Life of Frail Aged Patients in Incremental Hemodialysis N/A
Recruiting NCT02843334 - Study of the Prevalence of Fabry Disease in French Dialysis Patients N/A
Recruiting NCT02545530 - Transdermal Clonidine in Chronic Hemodialysis Patients N/A
Completed NCT00892749 - Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis Phase 3
Completed NCT00649298 - A Clinical Trial of IntensiVE Dialysis Phase 4