Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
Scientific title
Assessment of response to COVID-19 VaccinAtion in patients with chronic Kidney disease in New Zealand (C-VAK NZ study)
Secondary ID [1] 303859 0
Nil known
Universal Trial Number (UTN)
Trial acronym
C-VAK NZ study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant 321427 0
Dialysis 321428 0
Covid-19 321429 0
Condition category
Condition code
Renal and Urogenital 319191 319191 0 0
Kidney disease
Infection 319246 319246 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 320168 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327062 0
humoral responses measured by
1. Serology for Covid 19 - positive antibody response post vaccination for humoral response
Timepoint [1] 327062 0
1, 3 and 6 months post booster dose of vaccination
Primary outcome [2] 327154 0
Cellular responses measured using T cell responses post vaccination
specific assay to be determined

At 3 weeks post booster dose of vaccination
Timepoint [2] 327154 0
3 weeks post vaccination
Secondary outcome [1] 393658 0
Acute rejection - will be assessed by kidney biopsy if graft dysfunction
Timepoint [1] 393658 0
Post vaccination for 3 months at 1,4,8, and 12 weeks after booster vaccination
Secondary outcome [2] 393659 0
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
Timepoint [2] 393659 0
post vaccination as above- 3 monthly for one year

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
1/02/2022
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 23577 0
New Zealand
State/province [1] 23577 0

Funding & Sponsors
Funding source category [1] 308256 0
Government body
Name [1] 308256 0
Auckland District Health Board
Country [1] 308256 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
PArk Road
Grafton
Auckland, NZ 1023
Country
New Zealand
Secondary sponsor category [1] 309047 0
None
Name [1] 309047 0
Address [1] 309047 0
Country [1] 309047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308234 0
Northern B Health and Disability Ethics committee
Ethics committee address [1] 308234 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 308234 0
New Zealand
Date submitted for ethics approval [1] 308234 0
24/03/2021
Approval date [1] 308234 0
31/03/2021
Ethics approval number [1] 308234 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52094 0
A/Prof Helen Pilmore
Address 52094 0
Dept Renal Medicine,
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 52094 0
New Zealand
Phone 52094 0
+64 93797440
Fax 52094 0
Email 52094 0
hpilmore@adhb.govt.nz
Contact person for public queries
Name 52095 0
A/Prof Helen Pilmore
Address 52095 0
Dept Renal Medicine,
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 52095 0
New Zealand
Phone 52095 0
+64 93797440
Fax 52095 0
Email 52095 0
hpilmore@adhb.govt.nz
Contact person for scientific queries
Name 52096 0
A/Prof Helen Pilmore
Address 52096 0
Dept Renal Medicine,
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 52096 0
New Zealand
Phone 52096 0
+64 93797440
Fax 52096 0
Email 52096 0
hpilmore@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
patient individual data will be kept confidential


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.