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COVID-19 Vaccine Boosters in Patients With CKD | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

COVID-19 Vaccine Boosters in Patients With CKD

A Multi-Centre 12 Month Parallel-Group Randomized Control Trial of BNT162b2 Versus mRNA( Messenger Ribonucleic Acid) -1273 COVID-19 Vaccine Boosters in Chronic Kidney Disease and Dialysis Patients With Poor Humoral Response Following COVID-19 ( Corona Virus Disease of 2019)Vaccination

NCT05022329•Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

Summary

This study is a 12-month, four-arm parallel-group randomized control trial of Pfizer-BioNTech versus MODERNA COVID-19 (Corona Virus disease 2019)vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following COVID-19 vaccination, in collaboration with 5 dialysis centers in Ontario and British Columbia, Canada . Patients will be randomized to MODERNA or Pfizer-BioNTech COVID-19 vaccine, they may have received either MODERNA or Pfizer-BioNTech COVID-19 vaccine for their initial two doses of vaccine, and will be stratified by their initial vaccine type (MODERNA or Pfizer-BioNTech ) prior to randomization, which will result in four study groups.

Detailed Description

MODERNA : Nucleocapsid Modified messenger RNA BioNTech: Bio-Pharma new Technology

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with Chronic Kidney Disease (CKD)stage 3b-5 defined as an eGFR( estimated glomerular filtration rate ) of less than 45ml/min/1.73m2 or less will be eligible. Stage 5 CKD will include patients receiving in-center hemodialysis, home dialysis (home hemodialysis or peritoneal dialysis), vaccinated with two doses of the COVID-19 vaccine will be eligible for a third dose to be given 2-12 months following the second dose.
•Age ≥18 at the time of study enrolment

Exclusion Criteria

•Patients not vaccinated against COVID-19 vaccination.
•Patients who received heterologous first two doses of vaccine
•Patients with a severe allergic reaction to prior COVID-19 vaccination or any of the ingredients.
•New COVID-19 infection

Locations (3)

Scarborough Health Network

Scarborough Village, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Sunnybrook Health Science Center

Toronto, Ontario, Canada

Key Dates

Start Date

September 30, 2021

Primary Completion Date

May 11, 2022

Completion Date

November 15, 2022

Last Updated

February 19, 2025

Enrollment

273

ACTUAL participants

Conditions

Chronic Kidney DiseasesCOVID-19

Interventions

Pfizer-BioNTech COVID-19 Vaccine

BIOLOGICAL

MODERNA SARS-CoV-2 Vaccine

BIOLOGICAL

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COVID-19

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RECRUITINGNA

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Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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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: February 19, 2025Data 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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COVID-19 Vaccine Boosters in Patients With CKD

Inclusion Criteria

Exclusion Criteria

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