Kidney Transplant RecipientsCOVATRHUSNCT04757883
Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients
An observational study of Kidney Transplant Recipients, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2. The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Study of the synthesis of antibodies directed against SARS
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to 1 Nov 2024
- 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: kidney transplants
Who may be able to join
- Male or female, 18 years of age or older
- Patient vaccinated against SARS-CoV-2 as part of routine care
- Kidney or pancreatic kidney transplant
- Transplantation for more than 3 months
- Subject affiliated to a social protection health insurance
- Subject able to understand the objectives and risks of the research and to give signed and dated informed consent
Who cannot join
- History of anaphylactic shock or known allergy to PEG
- Known history of COVID or positive Covid serology in the 3 months prior to vaccination
- Contraindication to an intramuscular injection
- Impossibility to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject, ...)
- Subject under safeguard of justice
- Subject under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients
The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2.
The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. These patients will be vaccinated as part of routine care with a CoV-2 SARS vaccine licensed in France.
In this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against SARS CoV-2 and the specific cellular response of SARS Cov-2 by quantiferon and in vitro lymphocyte stimulation assays.
- Conditions
- Kidney Transplant Recipients
- Being tested
- Study of the synthesis of antibodies directed against SARS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of the synthesis of antibodies directed against SARSOther
Between 5 mL and 45 mL of additional blood will be collected to study the synthesis of antibodies against CoV-2 SARS and to investigate whether specialised immune cells also show an effective response against the virus.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Measured: Month 1 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Measured: Month 3 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Measured: Month 6 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Measured: Month 12 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Measured: Month 24 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start2 Feb 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Why it stopped: the required number of patients has been reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757883
- Sponsor's protocol ID
- 8135
- Acronym
- COVATRHUS
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT04757883
- Acronym / sponsor ID
- COVATRHUS / 8135
- Conditions
- Kidney Transplant Recipients
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the required number of patients has been reached
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 17 Feb 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.
The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2.
The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. These patients will be vaccinated as part of routine care with a CoV-2 SARS vaccine licensed in France.
In this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against SARS CoV-2 and the specific cellular response of SARS Cov-2 by quantiferon and in vitro lymphocyte stimulation assays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- kidney transplants
Key inclusion criteria (6 listed)
- Male or female, 18 years of age or older
- Patient vaccinated against SARS-CoV-2 as part of routine care
- Kidney or pancreatic kidney transplant
- Transplantation for more than 3 months
- Subject affiliated to a social protection health insurance
Key exclusion criteria (6 listed)
- History of anaphylactic shock or known allergy to PEG
- Known history of COVID or positive Covid serology in the 3 months prior to vaccination
- Contraindication to an intramuscular injection
- Impossibility to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject, ...)
- Subject under safeguard of justice
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 |
|---|---|---|
| Study of the synthesis of antibodies directed against SARSBetween 5 mL and 45 mL of additional blood will be collected to study the synthesis of antibodies against CoV-2 SARS and to investigate whether specialised immune cells also show an effective response against the virus. | Other | – |
Primary outcome
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time frame: Month 1 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time frame: Month 3 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time frame: Month 6 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time frame: Month 12 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time frame: Month 24 after vaccination
Results and safety
The study was stopped early (reason given: the required number of patients has been reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kidney Transplant Recipients, run by University Hospital, Strasbourg, France at 1 site in France.
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 19 Aug 2026. 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 France. 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: the required number of patients has been reached). 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?
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine. (time frame: Month 1 after vaccination). The study lists 5 primary outcomes in all. 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 19 Aug 2026.