End Stage Kidney DiseaseNCT04932876
The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
An observational study of End Stage Kidney Disease and Kidney Transplantion, run by University of Ioannina at 1 site in Greece.
Trial summary
Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Kidney Disease, Kidney Transplantion, Covid19
- What is being tested?
- SARS - COV 2 VACCINE
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 24 Apr 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End Stage Kidney Disease and Kidney Transplant Recipients
Who may be able to join
- Age >18 years
- Covid 19 vaccination
Who cannot join
- previous covid infection
- recent infection
- chronic infection
- HBV, HCV, HIV
- Active malignancy
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Evangelia Ntounousi
Ioannina, Epirus, 45110
Evangelia Ntounousi, PHD, edounous@uoi.gr
About this study
Official title: Assessment of the Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.
- Conditions
- End Stage Kidney Disease, Kidney Transplantion, Covid19, Vaccination
- Being tested
- SARS - COV 2 VACCINE
- Keywords
- End Stage Kidney Disease, Kindey Trasplantation, Immune System, Covid19 Vaccination
- Medical subject headings
- Kidney Failure, Chronic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS - COV 2 VACCINEBiological
Vaccination for SARS - COV 2
| Study group | Role | What they receive |
|---|---|---|
| ESKD - HD | End Stage Kidney Disease on Long Term Dialysis Receives: Biological: SARS - COV 2 VACCINE | |
| KTR | Kidney Transplant Recipient Receives: Biological: SARS - COV 2 VACCINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the vaccine
Humoral immune response to the vaccine as evaluated by generation of SARS-CoV-2 IgG II antibodies at two time points (before the second dose of the BNT162b2 vaccine and two weeks following the second dose of the BNT162b2 vaccine). Secondly, lympocyte subsets will be measured by flow cytometry (Naive and memeory T cells - CD45RO+, CD45 RA+, CD4+RO+, CD4+CDRA+, CD4+, CD8+, CD19+, NKT cells) at the two respective time points so as to assess alterations induced by vaccination. Serologic response will be estimated by measurement of anti SARS-CoV-2-spike IgGII titer (AU/ml) in the serum (using the ARCHITECT IgG II Quant test (Abbott); titers >50 arbitrary units (AU)/ml are considered positive (detection range, 6.8-80,000 AU/ml); positive agreement, 99.4%; negative agreement, 99.6%).
Measured: 24 months
Secondary outcomes (1)
Complications caused by the vaccine
Potential side effects associated with the vaccine shall be recorded. Percentages of lymphocytes subsets (as depicted before) in peripheral blood will be measured by flow cytometry. We will compare changes from baseline in the percentages of the lymphocytes subsets following the first and second dose of vaccination between the hemodialysis and kidney transplant recipeints group. In addition we will search for associations between percentages of lymphocytes subsets at diggerent measurement time points and antibody reponse.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start24 Apr 2021
- Primary completionDec 2021 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Ntounousi, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932876
- Sponsor's protocol ID
- RESCOMUOI82152
- Status last verified
- Sep 2021
- First submitted
- 19 May 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
- ClinicalTrials.gov ID
- NCT04932876
- Acronym / sponsor ID
- RESCOMUOI82152
- Conditions
- End Stage Kidney Disease, Kidney Transplantion, Covid19, Vaccination
- Keywords
- End Stage Kidney Disease, Kindey Trasplantation, Immune System, Covid19 Vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 24 Apr 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESKD - HD | – | Biological: SARS - COV 2 VACCINEEnd Stage Kidney Disease on Long Term Dialysis |
| KTR | – | Biological: SARS - COV 2 VACCINEKidney Transplant Recipient |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End Stage Kidney Disease and Kidney Transplant Recipients
Key inclusion criteria (2 listed)
- Age >18 years
- Covid 19 vaccination
Key exclusion criteria (5 listed)
- previous covid infection
- recent infection
- chronic infection
- HBV, HCV, HIV
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS - COV 2 VACCINEVaccination for SARS - COV 2 | Biological | ESKD - HD, KTR |
Primary outcome
Efficacy of the vaccine
Time frame: 24 months
Humoral immune response to the vaccine as evaluated by generation of SARS-CoV-2 IgG II antibodies at two time points (before the second dose of the BNT162b2 vaccine and two weeks following the second dose of the BNT162b2 vaccine). Secondly, lympocyte subsets will be measured by flow cytometry (Naive and memeory T cells - CD45RO+, CD45 RA+, CD4+RO+, CD4+CDRA+, CD4+, CD8+, CD19+, NKT cells) at the two respective time points so as to assess alterations induced by vaccination. Serologic response will be estimated by measurement of anti SARS-CoV-2-spike IgGII titer (AU/ml) in the serum (using the ARCHITECT IgG II Quant test (Abbott); titers >50 arbitrary units (AU)/ml are considered positive (detection range, 6.8-80,000 AU/ml); positive agreement, 99.4%; negative agreement, 99.6%).
1 secondary outcome
Complications caused by the vaccine
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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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.
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 and Kidney Transplantion, run by University of Ioannina at 1 site in Greece.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evangelia Ntounousi, PHD (+302651007429, edounous@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the vaccine (time frame: 24 months). 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 29 Sep 2021.