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Trial registered on ANZCTR
Registration number
ACTRN12621000460808
Ethics application status
Approved
Date submitted
1/04/2021
Date registered
20/04/2021
Date last updated
20/04/2021
Date data sharing statement initially provided
20/04/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
COVID-19 VaccinAtion in patients with chronic Kidney disease in New Zealand (C-VAK NZ study)
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Scientific title
Assessment of response to COVID-19 VaccinAtion in patients with chronic Kidney disease in New Zealand (C-VAK NZ study)
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Secondary ID [1]
303859
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
C-VAK NZ study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant
321427
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Dialysis
321428
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Covid-19
321429
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Condition category
Condition code
Renal and Urogenital
319191
319191
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0
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Kidney disease
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Infection
319246
319246
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0
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Assessment of serology for Covid -19 vaccination in kidney transplant and dialysis patients
Testing at 1 and 3 weeks post Covid Vaccination and 6 months post covid vaccination
follow up for one year with graft survival
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Intervention code [1]
320168
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Not applicable
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
327062
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humoral responses measured by
1. Serology for Covid 19 - positive antibody response post vaccination for humoral response
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Assessment method [1]
327062
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Timepoint [1]
327062
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1, 3 and 6 months post booster dose of vaccination
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Primary outcome [2]
327154
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Cellular responses measured using T cell responses post vaccination
specific assay to be determined
At 3 weeks post booster dose of vaccination
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Assessment method [2]
327154
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Timepoint [2]
327154
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3 weeks post vaccination
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Secondary outcome [1]
393658
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Acute rejection - will be assessed by kidney biopsy if graft dysfunction
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Assessment method [1]
393658
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Timepoint [1]
393658
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Post vaccination for 3 months at 1,4,8, and 12 weeks after booster vaccination
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Secondary outcome [2]
393659
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HLA antibodies by luminex assays - these are done routinely in all patients on the transplant waitlist 3 monthly and will be assessed for 1 year post vacciantion
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Assessment method [2]
393659
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Timepoint [2]
393659
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post vaccination as above- 3 monthly for one year
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Eligibility
Key inclusion criteria
o Adults aged 16 years and older.
o Patients with kidney failure on dialysis
o Kidney-only and simultaneous pancreas kidney transplant recipients, who are at least 3 months post transplantation.
o Planned to receive a vaccine for SARS-CoV-2
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
o Patients with current COVID-19 infection
o Patients with a proven current bacterial, viral, fungal or parasitic infection
o Pregnant
o Unable to give informed consent
o Refuse to get vaccinated
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2021
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Actual
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Date of last participant enrolment
Anticipated
1/02/2022
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Actual
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Date of last data collection
Anticipated
1/12/2022
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
23577
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New Zealand
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State/province [1]
23577
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Funding & Sponsors
Funding source category [1]
308256
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Government body
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Name [1]
308256
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Auckland District Health Board
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Address [1]
308256
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PArk Road
Grafton
Auckland, NZ 1023
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Country [1]
308256
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New Zealand
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Primary sponsor type
Government body
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Name
Auckland District Health Board
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Address
PArk Road
Grafton
Auckland, NZ 1023
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Country
New Zealand
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Secondary sponsor category [1]
309047
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None
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Name [1]
309047
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Address [1]
309047
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Country [1]
309047
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308234
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Northern B Health and Disability Ethics committee
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Ethics committee address [1]
308234
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
308234
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New Zealand
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Date submitted for ethics approval [1]
308234
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24/03/2021
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Approval date [1]
308234
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31/03/2021
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Ethics approval number [1]
308234
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Summary
Brief summary
This is an observational cohort study assessing the serological response to COVID-19 vaccination in kidney and kidney pancreas transplant recipients and patients treated with maintenance dialysis at Auckland City Hospital. Three analyses will be undertaken:
1. Vaccine immunogenicity based on humoral and cellular responses. Serological testing for the antibody to SARS-CoV-2 will be done prior to vaccination and again at 1 and 3 weeks and 6 months after the booster vaccination in dialysis and transplant recipients. Cellular responses will be assessed at 3 weeks after the booster vaccination.
2. Development of anti-HLA antibodies in dialysis patients on the kidney transplant waiting list in the first 12 months after vaccination.
3. Development of acute rejection episodes at 1, 4, 8 and 12 weeks after vaccination in recipients of kidney and kidney-pancreas transplants.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
52094
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A/Prof Helen Pilmore
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Address
52094
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Dept Renal Medicine,
Auckland City Hospital
Park Road
Grafton
Auckland 1023
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Country
52094
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New Zealand
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Phone
52094
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+64 93797440
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Fax
52094
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Email
52094
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[email protected]
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Contact person for public queries
Name
52095
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A/Prof Helen Pilmore
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Address
52095
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Dept Renal Medicine,
Auckland City Hospital
Park Road
Grafton
Auckland 1023
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Country
52095
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New Zealand
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Phone
52095
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+64 93797440
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Fax
52095
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Email
52095
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[email protected]
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Contact person for scientific queries
Name
52096
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A/Prof Helen Pilmore
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Address
52096
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Dept Renal Medicine,
Auckland City Hospital
Park Road
Grafton
Auckland 1023
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Country
52096
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New Zealand
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Phone
52096
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+64 93797440
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Fax
52096
0
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Email
52096
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
patient individual data will be kept confidential
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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