Study Stopped
Trial participants became eligible to receive their 4th dose of the COVID-19 vaccine vaccine thus data collected from the 12 month follow-up after 3rd dose vaccine, as per current protocol, would not not be relevant to the study outcomes.
COVID-19 Vaccine Boosters in Patients With CKD
BOOST KIDNEY
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
1 other identifier
interventional
273
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2021
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedResults Posted
Study results publicly available
February 19, 2025
CompletedFebruary 19, 2025
May 1, 2023
7 months
August 23, 2021
December 15, 2023
January 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
One month
Secondary Outcomes (9)
Serum Level of SARS-CoV-2 Antibodies
3 months
Serum Level of SARS-CoV-2 Antibodies
6 months
Serum Level of SARS-CoV-2 Antibodies
12 months
Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC)
1 month
Adverse Event
14 days
- +4 more secondary outcomes
Study Arms (4)
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1
EXPERIMENTALPatients who received two doses MODERNA vaccine, Arm 2
EXPERIMENTALPatients who received two doses Pfizer-BioNTech vaccine ,Arm 3
EXPERIMENTALPatients who received two doses MODERNA vaccine, Arm 4
EXPERIMENTALInterventions
This arm receives Pfizer-BioNTech COVID-19 Vaccine
This arm receives MODERNA SARS-CoV-2 Vaccine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- University Health Network, Torontocollaborator
- Unity Health Torontocollaborator
- Scarborough General Hospitalcollaborator
- Providence Healthcarecollaborator
Study Sites (3)
Scarborough Health Network
Scarborough Village, Ontario, M1P 2V5, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Sunnybrook Health Science Center
Toronto, Ontario, Canada
Related Publications (1)
Yau K, Tam P, Chan CT, Hu Q, Qi F, Abe KT, Kurtesi A, Jiang Y, Estrada-Codecido J, Brown T, Liu L, Siwakoti A, Leis JA, Levin A, Oliver MJ, Colwill K, Gingras AC, Hladunewich MA. BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):85-97. doi: 10.2215/CJN.0000000000000328. Epub 2023 Oct 17.
PMID: 37847518RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Yau
- Organization
- University Health Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 26, 2021
Study Start
September 30, 2021
Primary Completion
May 11, 2022
Study Completion
November 15, 2022
Last Updated
February 19, 2025
Results First Posted
February 19, 2025
Record last verified: 2023-05