End Stage Kidney DiseaseNCT04815850
Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study
An observational study of End Stage Kidney Disease, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Kidney Disease
- How many people
- 115 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 5 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving haemodialysis at Leicester General Hospital.
Who may be able to join
- End stage kidney disease on haemodialysis
- Able and willing to give informed consent
- Have completed or due to complete vaccination against COVID-19
Who cannot join
- Acute kidney injury requiring temporary haemodialysis
- Unable to give informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Leicester NHS Trust
Leicester, Leicestershire, LE5 4PW
About this study
Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. It is likely that patients on haemodialysis will be amongst the first people to be offered vaccination against COVID-19 when they become available. While any vaccines offered to these patients will be safe to receive, the effectiveness of the vaccines at giving immunity to being infected with COVID-19 are not known as they have not been explicitly tested in patients on haemodialysis. This study will involve having 3 blood tests to test for an antibody response following vaccination for COVID-19. The first will be 1 month after the first vaccination dose to look at the initial antibody response and the second and third will be 1 month and 6 months after the second vaccination dose.
Read the detailed description
Patients with end stage kidney disease (ESKD) on haemodialysis are more likely to suffer poorer outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This is likely to be because these patients have higher levels of co-morbid diseases and they are relatively immunosuppressed due to the effects of advanced kidney disease. The humoral response against common viral vaccination is known to be blunted in patients with ESKD and there are data to suggest seroconversion following infection with COVID-19 is blunted in patients with kidney disease. A successful programme of vaccination will undoubtedly improve outcomes for patients on haemodialysis, but vaccine testing programmes have not included patients with ESKD. Whilst initial press-coverage of the efficacy of vaccines which are available for use is promising, they are untested in patients on haemodialysis who are known to be relatively immunosuppressed as a result of their renal disease and as such the efficacy for this patient group is not known.
This study will phenotype the IgG antibody response to vaccination for COVID-19 in 100 patients on haemodialysis compared to 50 healthy volunteers. Antibody testing will be conducted at 1 month post first vaccination dose and 1 month and 6 months post second vaccination dose. This will give crucial information as to the efficacy of the vaccine and inform possible requirements for re-vaccination.
This study will:
- Phenotype the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 in patients on haemodialysis
- Compare the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 between patients on haemodialysis and healthy volunteers
- Conditions
- End Stage Kidney Disease
- Keywords
- haemodialysis, COVID-19, seroconversion, chronic kidney disease
- Medical subject headings
- Kidney Failure, Chronic, COVID-19, HIV Seropositivity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients on haemodialysis | Patients receiving haemodialysis | |
| Healthy controls | Participants with no chronic kidney disease or history of immunosuppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COVID-19 IgG Antibody (Relative Light Units)
Measured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels >1RLU (relative light units) reported as positive to an upper limit of 10)
Measured: 1 month post first vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Mar 2021
- Primary completion15 Feb 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Leicester Hospitals Charity, Francis Crick Institute
- Responsible party
- Sponsor
- Investigators
- Matthew PM Graham-Brown, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815850
- Sponsor's protocol ID
- 0810
- Status last verified
- May 2022
- First submitted
- 23 Mar 2021
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study
- ClinicalTrials.gov ID
- NCT04815850
- Acronym / sponsor ID
- 0810
- Conditions
- End Stage Kidney Disease
- Keywords
- haemodialysis, COVID-19, seroconversion, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Leicester Hospitals Charity, Francis Crick Institute
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 26 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. It is likely that patients on haemodialysis will be amongst the first people to be offered vaccination against COVID-19 when they become available. While any vaccines offered to these patients will be safe to receive, the effectiveness of the vaccines at giving immunity to being infected with COVID-19 are not known as they have not been explicitly tested in patients on haemodialysis. This study will involve having 3 blood tests to test for an antibody response following vaccination for COVID-19. The first will be 1 month after the first vaccination dose to look at the initial antibody response and the second and third will be 1 month and 6 months after the second vaccination dose.
Detailed description
Patients with end stage kidney disease (ESKD) on haemodialysis are more likely to suffer poorer outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This is likely to be because these patients have higher levels of co-morbid diseases and they are relatively immunosuppressed due to the effects of advanced kidney disease. The humoral response against common viral vaccination is known to be blunted in patients with ESKD and there are data to suggest seroconversion following infection with COVID-19 is blunted in patients with kidney disease. A successful programme of vaccination will undoubtedly improve outcomes for patients on haemodialysis, but vaccine testing programmes have not included patients with ESKD. Whilst initial press-coverage of the efficacy of vaccines which are available for use is promising, they are untested in patients on haemodialysis who are known to be relatively immunosuppressed as a result of their renal disease and as such the efficacy for this patient group is not known.
This study will phenotype the IgG antibody response to vaccination for COVID-19 in 100 patients on haemodialysis compared to 50 healthy volunteers. Antibody testing will be conducted at 1 month post first vaccination dose and 1 month and 6 months post second vaccination dose. This will give crucial information as to the efficacy of the vaccine and inform possible requirements for re-vaccination.
This study will:
- Phenotype the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 in patients on haemodialysis
- Compare the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 between patients on haemodialysis and healthy volunteers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients on haemodialysis | – | –Patients receiving haemodialysis |
| Healthy controls | – | –Participants with no chronic kidney disease or history of immunosuppression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving haemodialysis at Leicester General Hospital.
Key inclusion criteria (3 listed)
- End stage kidney disease on haemodialysis
- Able and willing to give informed consent
- Have completed or due to complete vaccination against COVID-19
Key exclusion criteria (3 listed)
- Acute kidney injury requiring temporary haemodialysis
- Unable to give informed consent
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in COVID-19 IgG Antibody (Relative Light Units)
Time frame: 1 month post first vaccine
Measured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels >1RLU (relative light units) reported as positive to an upper limit of 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew PM Graham-Brown principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Kidney Disease, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COVID-19 IgG Antibody (Relative Light Units) (time frame: 1 month post first vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.