Chronic Kidney DiseasesCOVID-thIRdNCT05142501
Observation of the Immune Response After COVID-19 Additional Vaccine Doses in Chronic Patients in Hemodialysis Therapy
An observational study of Chronic Kidney Diseases and COVID-19, run by Fresenius Medical Care Deutschland GmbH at 11 sites in 2 countries.
Trial summary
Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, COVID-19, Hemodialysis
- What is being tested?
- Blood samples
- How many people
- 23 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 25 Apr 2022to 2 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prevalent hemodialysis patients treated who receive three hemodialysis treatments per week.
Who may be able to join
- Informed consent signed and dated by study patient and investigator/authorized physician
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study
- ESKD patients on maintenance hemodialysis with a minimum of 4hrs three times a week at the time of recruitment and a dialysis vintage ≥3 months in NC clinics
- Patients that already received three doses against COVID-19 as detailed in the manufacturer's instructions
- Patients that are scheduled to receive a fourth vaccine dose of either Comirnaty (BioNTech/Pfizer) or Spikevax (Moderna) after approval of respective national authority.
Who cannot join
- Any conditions which could interfere with the patient's ability to comply with the study
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Patients with proven current COVID-19 infection as identified by routine clinical practice
- Patient in therapy with immunosuppressive medications / immunomodulators
- Patients who already received a fourth COVID-19 vaccination dose
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Spain7 sites
Centro de Diálisis Barcelona - Glories
Barcelona, 08013
Centro de Diálisis Barcelona - Rosselló
Barcelona, 08029
Centro de Diálisis Granollers
Granollers, 08401
Centro de Diálisis Dialcentro
Madrid, 28009
Centro de Diálisis San Luciano
Madrid, 28041
Centro de Diálisis Sant Boi
Sant Boi de Llobregat, 08830
Centro de Diálisis Terrassa
Terrassa, 08223
Portugal4 sites
NephroCare Amadora
Amadora, 2700-391
NephroCare Restelo
Lisbon, 1400-195
NephroCare Lumiar
Lisbon, 1750-130
NephroCare Vila Franca de Xira
Vila Franca de Xira, 2600-076
About this study
Official title: Observation of Humoral and Cellular Immune Response After Additional Vaccine Dose With Different COVID-19 Vaccines in ESKD Patients in Hemodialysis Therapy
Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.
Read the detailed description
In this open, prospective, observational trial the humoral and cellular immune response in ESKD patients undergoing hemodialysis shall be analyzed after administration of a fourth dose of vaccine. The total follow-up time per patient is up to 12 months after the fourth dose of vaccine.
In total, 340 patients (170 patients per country) shall be included. Only adult patients capable of giving consent will be enrolled. The humoral immune response will be analyzed in all patients, whereas the analysis of the cellular immune response will only be conducted in 15% of the enrolled patients.
The HD-COVID-IR-EU study shall be conducted in Portugal and in Spain.
- Conditions
- Chronic Kidney Diseases, COVID-19, Hemodialysis
- Being tested
- Blood samples
- Keywords
- Chronic Kidney Disease, COVID-19, Immune responses
- Medical subject headings
- Renal Insufficiency, Chronic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Four consecutive blood sampling throughout the overall follow-up period of 12 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immune response
The humoral immune response will be assessed at four different timepoints (Sample 1: prior to the fourth vaccine dose; sample 2: 1 months after the fourth vaccine dose; sample 3: 6 months after the fourth vaccine dose; sample 4: 12 months after the fourth vaccine dose or max. 4 weeks prior to the fifth vaccine dose, whichever comes first) through the measurement of the titers of Bioplex IgG antibody panel in study participant's blood samples.
Measured: 12 months after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start25 Apr 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Ponce, Dr, Principal investigator, Nephrocare PortugalMaria Eva Baró Salvador, Dr, Principal investigator, Fresenius Medical Care España, S.A.U.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142501
- Sponsor's protocol ID
- HD-COVID-IR-EU
- Acronym
- COVID-thIRd
- Status last verified
- Sep 2022
- First submitted
- 1 Dec 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Humoral and Cellular Immune Response After Additional Vaccine Dose With Different COVID-19 Vaccines in ESKD Patients in Hemodialysis Therapy
- ClinicalTrials.gov ID
- NCT05142501
- Acronym / sponsor ID
- COVID-thIRd / HD-COVID-IR-EU
- Conditions
- Chronic Kidney Diseases, COVID-19, Hemodialysis
- Keywords
- Chronic Kidney Disease, COVID-19, Immune responses
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 2 Dec 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.
Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.
Detailed description
In this open, prospective, observational trial the humoral and cellular immune response in ESKD patients undergoing hemodialysis shall be analyzed after administration of a fourth dose of vaccine. The total follow-up time per patient is up to 12 months after the fourth dose of vaccine.
In total, 340 patients (170 patients per country) shall be included. Only adult patients capable of giving consent will be enrolled. The humoral immune response will be analyzed in all patients, whereas the analysis of the cellular immune response will only be conducted in 15% of the enrolled patients.
The HD-COVID-IR-EU study shall be conducted in Portugal and in Spain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prevalent hemodialysis patients treated who receive three hemodialysis treatments per week.
Key inclusion criteria (6 listed)
- Informed consent signed and dated by study patient and investigator/authorized physician
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study
- ESKD patients on maintenance hemodialysis with a minimum of 4hrs three times a week at the time of recruitment and a dialysis vintage ≥3 months in NC clinics
- Patients that already received three doses against COVID-19 as detailed in the manufacturer's instructions
Key exclusion criteria (6 listed)
- Any conditions which could interfere with the patient's ability to comply with the study
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Patients with proven current COVID-19 infection as identified by routine clinical practice
- Patient in therapy with immunosuppressive medications / immunomodulators
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 |
|---|---|---|
| Blood samplesFour consecutive blood sampling throughout the overall follow-up period of 12 months. | Other | – |
Primary outcome
Humoral immune response
Time frame: 12 months after start of study
The humoral immune response will be assessed at four different timepoints (Sample 1: prior to the fourth vaccine dose; sample 2: 1 months after the fourth vaccine dose; sample 3: 6 months after the fourth vaccine dose; sample 4: 12 months after the fourth vaccine dose or max. 4 weeks prior to the fifth vaccine dose, whichever comes first) through the measurement of the titers of Bioplex IgG antibody panel in study participant's blood samples.
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Pedro Ponce, Dr principal investigator
Nephrocare Portugal
Maria Eva Baró Salvador, Dr principal investigator
Fresenius Medical Care España, S.A.U.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and COVID-19, run by Fresenius Medical Care Deutschland GmbH at 11 sites in 2 countries.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Portugal. 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?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Humoral immune response (time frame: 12 months after start of study). 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 15 Sep 2022.