Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
[email protected]
Contact person for public queries
Name 52095 0
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
[email protected]
Contact person for scientific queries
Name 52096 0
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
[email protected]

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.