Covid19LESS CoV-2NCT04841785
RECOVAC - Long Term Efficacy and Safety of COVID-19 (SARS-CoV-2) Vaccination in Kidney Disease Patients
An observational study of Covid19 and SARS-CoV Infection, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection, Chronic Kidney Diseases
- What is being tested?
- mailer-based finger-prick
- How many people
- 4,868 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Apr 2021to 18 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients with chronic kidney disease stage G4-G5 from the Santeon registry * Patients on hemodialysis and peritoneal dialysis who gave informed consent for participating in the national registry RENINEKidney transplant recipients who gave informed consent for participating in the national registry NOTR
Who may be able to join
- Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
- Age of 18 years or older
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- Either
- eGFR < 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
- Hemodialysis, or peritoneal dialysis
- Kidney Transplant recipient at least 6 weeks after transplantation
Who cannot join
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- Patients who opted out for research in the Santeon, RENINE and NOTR registries.
- Patients who participate in the RECOVAC-IR study.
- Of note, patients will be eligible whether or not they have a history of COVID-19. Analyses will be performed in the overall population, but also shown separately for those without and with a history of COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The RECOVAC LESS CoV-2 Study - Long Term Efficacy and Safety of SARS-CoV-2 Vaccination in Patients in Patients With Chronic Kidney Disease Stage G4-G5, on Dialysis or After Kidney Transplantation
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups.
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination.
Read more
Study design: prospective single center observational cohort study.
Study population:
- all Dutch patients on dialysis with data registered in the Dutch Dialysis registry (RENINE)
- all Dutch patients after kidney transplantation with data registered in the Dutch national kidney transplant registry (NOTR).
- All Dutch patients with chronic kidney disease stage G4-G5 registered in the Santeon hospitals.
Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn for antibody response measurements at day 28 and month 6 after 2nd vaccination at by mailer-based finger-prick in 3400 hemodialysis patients, 600 peritoneal dialysis patients, 4000 patients after kidney transplantation and 4000 patients with chronic kidney disease stage G4-G5. Patients who will undergo a 3rd SARS-CoV-2 vaccination via the national vaccination program for immunocompromised patients will be asked to carry out the mailer-based finger-prick 28 days after the 3rd SARS-CoV-2 vaccination, instead of the antibody measurement 6 months after the 2nd SARS-CoV-2 vaccination.
Main study parameters/endpoints:
The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as:
- the incidence of COVID-19 after vaccination.
Secondary endpoints are
- mortality
- adverse events of specific interest according to (inter)national authorities in collaboration with LAREB
- presence of HLA-antibodies in dialysis patients on the waiting list for a first kidney transplantation
- acute rejection and graft failure in patients after kidney transplantation In a subset of patients additional secondary endpoints will be assessed
- the antibody based immune response at 28 days after completion of SARS-CoV-2 vaccination.
- the durability of antibody based immune response at 6 months compared to at 28 days after having received two subsequent SARS-CoV-2 vaccinations, in patients that have not received a 3rd SARS-CoV-2 vaccine.
- the antibody based immune response at 28 days after having received the 3rd SARS-CoV-2 vaccination.
The incidence of these endpoints will be compared, if applicable, to those:
- in the general population who are vaccinated
- in patients on dialysis or after kidney transplant who are not vaccinated Within these patient groups endpoints will be compared between recipients of different vaccines.
Read the detailed description
- OBJECTIVES Primary objective: To assess the efficacy of SARS-CoV-2 vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination Secondary Objectives:
- To assess the safety of vaccination In a subgroup of participants:
- To assess the level of antibody response at 28 days and 6 months after SARS-CoV-2 vaccination
- To assess durability of the antibody response at 6 months after having received two subsequent SARS-CoV-2 vaccinations, in a subset of patients that have not received a 3rd SARS-CoV-2 vaccine
- the antibody based immune response at 28 days after having received the 3rd SARS-CoV-2 vaccination. Exploratory Objectives:
- The vaccination coverage rate
- The severity of COVID-19 in case of infection
- The influence of vaccination on health-related quality of life by patient reported outcome measures (PROMs) in patients on dialysis.
- The SARS-CoV-2 genotype in patients with COVID-19 In a subgroup of participants:
- To assess the level of antibody response after vaccination between patients with COVID-19 and without COVID-19 at:
- 28 days after the 2nd SARS-CoV-2 vaccination
- 28 days after the 3rd SARS-CoV-2 vaccination
- 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccine.
- To assess change in behaviour towards measures against COVID-19 before and after vaccination If data are available and applicable, outcomes in vaccinated patients on dialysis or after kidney transplantation will be compared:
- with outcomes in the general population
- with outcomes in patients with severely impaired kidney function (CKD stages G4/5), on dialysis or with a kidney transplant who are not vaccinated.
- according to the type of vaccination they received
- STUDY DESIGN This is a prospective observational registry-based cohort study to evaluate the long-term efficacy and safety after SARS-CoV-2 vaccination on clinically important outcomes in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. All participants will receive vaccination against COVID-19 via the national vaccination program and according to the manufacturer's instructions. To assess the immune response after vaccination, blood samples will be collected at 28 days after the 2nd SARS-CoV-2 vaccination, 28 days after the 3rd SARS-CoV-2 vaccination, and 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccination. In total a maximum of 1 ml blood will be drawn. Data of the following cohorts will be analyzed in this study.
- Patiens with chronic kidney disease stage G4-G5, data to be derived from the Santeon hospitals.
- Patients on hemodialysis and peritoneal dialysis, data to be derived from the existing national registry RENINE
- Kidney transplant recipients, data to be derived from the existing national registry NOTR
- Patients on dialysis or after kidney transplantation with COVID-19 disease, data to be derived from the ERACODA database.
- METHODS
Main study parameter/endpoint:
The primary endpoints is the incidence of COVID-19 in a two years period after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
Secondary study parameters/endpoints:
Safety in all patients:
- Incidence of mortality
- Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB
- Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation
- Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation
Efficacy in a subgroup of patients:
- The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the final SARS-CoV-2 vaccination.
- The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the 3rd SARS-CoV-2 vaccination.
- The durability of antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2 vaccination in patients who did not receive a 3rd SARS-CoV-2 vaccination.
Exploratory study parameters:
- Vaccination coverage rates
- Disease severity in patients who develop COVID-19, assessed as
- Hospitalization
- ICU admission
- Mechanical ventilation
- Mortality
- The influence of vaccination on health-related quality of life by patient reported outcome measures (PROMs) in dialysis patients
- SARS-CoV-2 genotype in patients with COVID-19
In a subgroup of participants:
- To assess the level of SARS-CoV-2 Receptor Binding Domain antibody response after vaccination between patients with COVID-19 and without COVID-19 at:
- 28 days after the 2nd SARS-CoV-2 vaccination
- 28 days after the 3rd SARS-CoV-2 vaccination
- 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccine.
- To assess change in behaviour towards measures against COVID-19 before and after vaccination
These data collected after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and after a kidney transplantation will (if applicable data are available) be compared:
- to those obtained in the general population
- to those obtained in patients with chronic kidney disease stage G4-G5, on dialysis or with a kidney transplant who are not vaccinated
- according to the type of vaccination received These comparisons will allow us to analyze whether SARS-CoV-2 vaccination offers efficacy to prevent COVID-19 and sufficient safety in patients with chronic kidney disease stage G4-G5, dialysis and kidney transplant patients when compared to non-vaccinated patients with chronic kidney disease stage G4-G5, dialysis and kidney transplant patients, whether the efficacy is similar as in the general population, and whether there are differences in the risk-benefit ratio between the various vaccines.
- Conditions
- Covid19, SARS-CoV Infection, Chronic Kidney Diseases
- Being tested
- mailer-based finger-prick
- Keywords
- Kidney transplant recipients, Dialysis, Chronic kidney disease stage 4-5, SARS-CoV-2 vaccination, COVID-19 vaccination, Antibody based immune response
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mailer-based finger-prickDiagnostic test
Also called blood withdrawel
All participants in the antibody measurement study will be sent a mailer-based finger-prick set. The sets will be sent to the home address of the patient, including a return envelope. After collecting and returning the samples SARS-CoV-2 antibodies will be analysed quantitatively at the laboratory.
| Study group | Role | What they receive |
|---|---|---|
| CKD4/5 | Patients with chronic kidney disease stage G4-G5 without dialysis or with a kidney transplant Receives: Diagnostic Test: mailer-based finger-prick | |
| Dialysis | Patients on hemodialysis and peritoneal dialysis Receives: Diagnostic Test: mailer-based finger-prick | |
| Kidney transplant | Patients with a kidney transplant at least 6 weeks after transplantation Receives: Diagnostic Test: mailer-based finger-prick |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of COVID-19
After SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
Measured: two years after SARS-CoV-2 vaccination
Secondary outcomes (7)
Incidence of mortality
Incidence of mortality in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
Measured: two years after SARS-CoV-2 vaccination
Incidence of adverse events
Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB
Measured: two years after SARS-CoV-2 vaccination
Incidence of acute rejection or graft failure in kidney transplant recipients
Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation
Measured: two years after SARS-CoV-2 vaccination
Incidence of HLA antibodies measured in blood
Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation
Measured: two years after SARS-CoV-2 vaccination
The antibody level against the SARS-CoV-2 Receptor Binding Domain measured in blood
The antibody response against the SARS-CoV-2 Receptor Binding Domain
Measured: 28 days after second SARS-CoV-2 vaccination.
The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood
The antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2 vaccination in patients without a third vaccination.
Measured: 6 months after second SARS-CoV-2 vaccination
The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood
The antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 28 days after a third vaccination
Measured: 28 days after third SARS-CoV-2 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start22 Apr 2021
- Primary completion30 Nov 2021
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 4,868 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.S.F. Sanders, University Medical Center Groningen
- Investigators
- Jan-Stephan F Sanders, MD PhD, Study director, University Medical Center GroningenMarc H Hemmelder, MD PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841785
- Sponsor's protocol ID
- NL76839.042.21
- Acronym
- LESS CoV-2
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahn C, Amer H, Anglicheau D, Ascher NL, Baan CC, Battsetset G, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon RM, Cantarovich M, Chan A, Chen ZS, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond JC, Farrero M, Friend PJ, Geissler EK, Ha J, Haberal MA, Henderson ML, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre CM, Man K, Moulin B, Muller E, Munkhbat R, Od-Erdene L, Perrin P, Rela M, Tanabe K, Tedesco Silva H, Tinckam KT, Tullius SG, Wong G. Global Transplantation COVID Report March 2020. Transplantation. 2020 Oct;104(10):1974-1983. doi: 10.1097/TP.0000000000003258. No abstract available.
PubMed 32243281Baric RS. Emergence of a Highly Fit SARS-CoV-2 Variant. N Engl J Med. 2020 Dec 31;383(27):2684-2686. doi: 10.1056/NEJMcibr2032888. Epub 2020 Dec 16. No abstract available.
PubMed 33326716Robison SF, Mayhew RB, Cowan RD, Hawley RJ. Comparative study of deflection characteristics and fragility of 25-, 27-, and 30-gauge short dental needles. J Am Dent Assoc. 1984 Dec;109(6):920-4. doi: 10.14219/jada.archive.1984.0246. No abstract available.
PubMed 6595298Berends SE, Bloem K, de Vries A, Schaap T, Rispens T, Strik AS, Talwar R, Lowenberg M, D'Haens GR, Mathot RA. Monitoring of Adalimumab Concentrations at Home in Patients with Inflammatory Bowel Disease Using Dried Blood Samples. Ther Drug Monit. 2020 Apr;42(2):289-294. doi: 10.1097/FTD.0000000000000686.
PubMed 31464823Dearlove B, Lewitus E, Bai H, Li Y, Reeves DB, Joyce MG, Scott PT, Amare MF, Vasan S, Michael NL, Modjarrad K, Rolland M. A SARS-CoV-2 vaccine candidate would likely match all currently circulating variants. Proc Natl Acad Sci U S A. 2020 Sep 22;117(38):23652-23662. doi: 10.1073/pnas.2008281117. Epub 2020 Aug 31.
PubMed 32868447ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314.
PubMed 33340043Gansevoort RT, Hilbrands LB. CKD is a key risk factor for COVID-19 mortality. Nat Rev Nephrol. 2020 Dec;16(12):705-706. doi: 10.1038/s41581-020-00349-4.
PubMed 32848205Gezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020; publicatienr. 2020/23
Hilbrands LB, Duivenvoorden R, Vart P, Franssen CFM, Hemmelder MH, Jager KJ, Kieneker LM, Noordzij M, Pena MJ, Vries H, Arroyo D, Covic A, Crespo M, Goffin E, Islam M, Massy ZA, Montero N, Oliveira JP, Roca Munoz A, Sanchez JE, Sridharan S, Winzeler R, Gansevoort RT; ERACODA Collaborators. COVID-19-related mortality in kidney transplant and dialysis patients: results of the ERACODA collaboration. Nephrol Dial Transplant. 2020 Nov 1;35(11):1973-1983. doi: 10.1093/ndt/gfaa261.
PubMed 33151337Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021 Feb;21(2):e26-e35. doi: 10.1016/S1473-3099(20)30773-8. Epub 2020 Oct 27.
PubMed 33125914Katerinis I, Hadaya K, Duquesnoy R, Ferrari-Lacraz S, Meier S, van Delden C, Martin PY, Siegrist CA, Villard J. De novo anti-HLA antibody after pandemic H1N1 and seasonal influenza immunization in kidney transplant recipients. Am J Transplant. 2011 Aug;11(8):1727-33. doi: 10.1111/j.1600-6143.2011.03604.x. Epub 2011 Jun 14.
PubMed 21672157Kotton CN. Immunization after kidney transplantation-what is necessary and what is safe? Nat Rev Nephrol. 2014 Oct;10(10):555-62. doi: 10.1038/nrneph.2014.122. Epub 2014 Jul 29.
PubMed 25072119Mahase E. Covid-19: Vaccine candidate may be more than 90% effective, interim results indicate. BMJ. 2020 Nov 9;371:m4347. doi: 10.1136/bmj.m4347. No abstract available.
PubMed 33168562Noordzij M, Duivenvoorden R, Pena MJ, de Vries H, Kieneker LM; collaborative ERACODA authors. ERACODA: the European database collecting clinical information of patients on kidney replacement therapy with COVID-19. Nephrol Dial Transplant. 2020 Dec 4;35(12):2023-2025. doi: 10.1093/ndt/gfaa179. No abstract available.
PubMed 32785669Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
PubMed 33301246
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RECOVAC LESS CoV-2 Study - Long Term Efficacy and Safety of SARS-CoV-2 Vaccination in Patients in Patients With Chronic Kidney Disease Stage G4-G5, on Dialysis or After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04841785
- Acronym / sponsor ID
- LESS CoV-2 / NL76839.042.21
- Conditions
- Covid19, SARS-CoV Infection, Chronic Kidney Diseases
- Keywords
- Kidney transplant recipients, Dialysis, Chronic kidney disease stage 4-5, SARS-CoV-2 vaccination, COVID-19 vaccination, Antibody based immune response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,868 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 12 Apr 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.
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups.
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination.
Study design: prospective single center observational cohort study.
Study population:
- all Dutch patients on dialysis with data registered in the Dutch Dialysis registry (RENINE)
- all Dutch patients after kidney transplantation with data registered in the Dutch national kidney transplant registry (NOTR).
- All Dutch patients with chronic kidney disease stage G4-G5 registered in the Santeon hospitals.
Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn for antibody response measurements at day 28 and month 6 after 2nd vaccination at by mailer-based finger-prick in 3400 hemodialysis patients, 600 peritoneal dialysis patients, 4000 patients after kidney transplantation and 4000 patients with chronic kidney disease stage G4-G5. Patients who will undergo a 3rd SARS-CoV-2 vaccination via the national vaccination program for immunocompromised patients will be asked to carry out the mailer-based finger-prick 28 days after the 3rd SARS-CoV-2 vaccination, instead of the antibody measurement 6 months after the 2nd SARS-CoV-2 vaccination.
Main study parameters/endpoints:
The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as:
- the incidence of COVID-19 after vaccination.
Secondary endpoints are
- mortality
- adverse events of specific interest according to (inter)national authorities in collaboration with LAREB
- presence of HLA-antibodies in dialysis patients on the waiting list for a first kidney transplantation
- acute rejection and graft failure in patients after kidney transplantation In a subset of patients additional secondary endpoints will be assessed
- the antibody based immune response at 28 days after completion of SARS-CoV-2 vaccination.
- the durability of antibody based immune response at 6 months compared to at 28 days after having received two subsequent SARS-CoV-2 vaccinations, in patients that have not received a 3rd SARS-CoV-2 vaccine.
- the antibody based immune response at 28 days after having received the 3rd SARS-CoV-2 vaccination.
The incidence of these endpoints will be compared, if applicable, to those:
- in the general population who are vaccinated
- in patients on dialysis or after kidney transplant who are not vaccinated Within these patient groups endpoints will be compared between recipients of different vaccines.
Detailed description
- OBJECTIVES Primary objective: To assess the efficacy of SARS-CoV-2 vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination Secondary Objectives:
- To assess the safety of vaccination In a subgroup of participants:
- To assess the level of antibody response at 28 days and 6 months after SARS-CoV-2 vaccination
- To assess durability of the antibody response at 6 months after having received two subsequent SARS-CoV-2 vaccinations, in a subset of patients that have not received a 3rd SARS-CoV-2 vaccine
- the antibody based immune response at 28 days after having received the 3rd SARS-CoV-2 vaccination. Exploratory Objectives:
- The vaccination coverage rate
- The severity of COVID-19 in case of infection
- The influence of vaccination on health-related quality of life by patient reported outcome measures (PROMs) in patients on dialysis.
- The SARS-CoV-2 genotype in patients with COVID-19 In a subgroup of participants:
- To assess the level of antibody response after vaccination between patients with COVID-19 and without COVID-19 at:
- 28 days after the 2nd SARS-CoV-2 vaccination
- 28 days after the 3rd SARS-CoV-2 vaccination
- 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccine.
- To assess change in behaviour towards measures against COVID-19 before and after vaccination If data are available and applicable, outcomes in vaccinated patients on dialysis or after kidney transplantation will be compared:
- with outcomes in the general population
- with outcomes in patients with severely impaired kidney function (CKD stages G4/5), on dialysis or with a kidney transplant who are not vaccinated.
- according to the type of vaccination they received
- STUDY DESIGN This is a prospective observational registry-based cohort study to evaluate the long-term efficacy and safety after SARS-CoV-2 vaccination on clinically important outcomes in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. All participants will receive vaccination against COVID-19 via the national vaccination program and according to the manufacturer's instructions. To assess the immune response after vaccination, blood samples will be collected at 28 days after the 2nd SARS-CoV-2 vaccination, 28 days after the 3rd SARS-CoV-2 vaccination, and 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccination. In total a maximum of 1 ml blood will be drawn. Data of the following cohorts will be analyzed in this study.
- Patiens with chronic kidney disease stage G4-G5, data to be derived from the Santeon hospitals.
- Patients on hemodialysis and peritoneal dialysis, data to be derived from the existing national registry RENINE
- Kidney transplant recipients, data to be derived from the existing national registry NOTR
- Patients on dialysis or after kidney transplantation with COVID-19 disease, data to be derived from the ERACODA database.
- METHODS
Main study parameter/endpoint:
The primary endpoints is the incidence of COVID-19 in a two years period after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
Secondary study parameters/endpoints:
Safety in all patients:
- Incidence of mortality
- Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB
- Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation
- Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation
Efficacy in a subgroup of patients:
- The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the final SARS-CoV-2 vaccination.
- The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the 3rd SARS-CoV-2 vaccination.
- The durability of antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2 vaccination in patients who did not receive a 3rd SARS-CoV-2 vaccination.
Exploratory study parameters:
- Vaccination coverage rates
- Disease severity in patients who develop COVID-19, assessed as
- Hospitalization
- ICU admission
- Mechanical ventilation
- Mortality
- The influence of vaccination on health-related quality of life by patient reported outcome measures (PROMs) in dialysis patients
- SARS-CoV-2 genotype in patients with COVID-19
In a subgroup of participants:
- To assess the level of SARS-CoV-2 Receptor Binding Domain antibody response after vaccination between patients with COVID-19 and without COVID-19 at:
- 28 days after the 2nd SARS-CoV-2 vaccination
- 28 days after the 3rd SARS-CoV-2 vaccination
- 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccine.
- To assess change in behaviour towards measures against COVID-19 before and after vaccination
These data collected after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and after a kidney transplantation will (if applicable data are available) be compared:
- to those obtained in the general population
- to those obtained in patients with chronic kidney disease stage G4-G5, on dialysis or with a kidney transplant who are not vaccinated
- according to the type of vaccination received These comparisons will allow us to analyze whether SARS-CoV-2 vaccination offers efficacy to prevent COVID-19 and sufficient safety in patients with chronic kidney disease stage G4-G5, dialysis and kidney transplant patients when compared to non-vaccinated patients with chronic kidney disease stage G4-G5, dialysis and kidney transplant patients, whether the efficacy is similar as in the general population, and whether there are differences in the risk-benefit ratio between the various vaccines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD4/5 | – | Diagnostic Test: mailer-based finger-prickPatients with chronic kidney disease stage G4-G5 without dialysis or with a kidney transplant |
| Dialysis | – | Diagnostic Test: mailer-based finger-prickPatients on hemodialysis and peritoneal dialysis |
| Kidney transplant | – | Diagnostic Test: mailer-based finger-prickPatients with a kidney transplant at least 6 weeks after transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with chronic kidney disease stage G4-G5 from the Santeon registry * Patients on hemodialysis and peritoneal dialysis who gave informed consent for participating in the national registry RENINEKidney transplant recipients who gave informed consent for participating in the national registry NOTR
Key inclusion criteria (7 listed)
- Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
- Age of 18 years or older
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- Either
Key exclusion criteria (4 listed)
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- Patients who opted out for research in the Santeon, RENINE and NOTR registries.
- Patients who participate in the RECOVAC-IR study.
- Of note, patients will be eligible whether or not they have a history of COVID-19. Analyses will be performed in the overall population, but also shown separately for those without and with a history of COVID-19.
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 |
|---|---|---|
| mailer-based finger-prickAlso: blood withdrawelAll participants in the antibody measurement study will be sent a mailer-based finger-prick set. The sets will be sent to the home address of the patient, including a return envelope. After collecting and returning the samples SARS-CoV-2 antibodies will be analysed quantitatively at the laboratory. | Diagnostic test | CKD4/5, Dialysis, Kidney transplant |
Primary outcome
The incidence of COVID-19
Time frame: two years after SARS-CoV-2 vaccination
After SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
7 secondary outcomes
Incidence of mortality
Time frame: two years after SARS-CoV-2 vaccination
Incidence of adverse events
Time frame: two years after SARS-CoV-2 vaccination
Incidence of acute rejection or graft failure in kidney transplant recipients
Time frame: two years after SARS-CoV-2 vaccination
Incidence of HLA antibodies measured in blood
Time frame: two years after SARS-CoV-2 vaccination
The antibody level against the SARS-CoV-2 Receptor Binding Domain measured in blood
Time frame: 28 days after second SARS-CoV-2 vaccination.
The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood
Time frame: 6 months after second SARS-CoV-2 vaccination
The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood
Time frame: 28 days after third SARS-CoV-2 vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 32243281Ahn C, Amer H, Anglicheau D, Ascher NL, Baan CC, Battsetset G, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon RM, Cantarovich M, Chan A, Chen ZS, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond JC, Farrero M, Friend PJ, Geissler EK, Ha J, Haberal MA, Henderson ML, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre CM, Man K, Moulin B, Muller E, Munkhbat R, Od-Erdene L, Perrin P, Rela M, Tanabe K, Tedesco Silva H, Tinckam KT, Tullius SG, Wong G. Global Transplantation COVID Report March 2020. Transplantation. 2020 Oct;104(10):1974-1983. doi: 10.1097/TP.0000000000003258. No abstract available.
- Results publication: PubMed 33326716Baric RS. Emergence of a Highly Fit SARS-CoV-2 Variant. N Engl J Med. 2020 Dec 31;383(27):2684-2686. doi: 10.1056/NEJMcibr2032888. Epub 2020 Dec 16. No abstract available.
- Results publication: PubMed 6595298Robison SF, Mayhew RB, Cowan RD, Hawley RJ. Comparative study of deflection characteristics and fragility of 25-, 27-, and 30-gauge short dental needles. J Am Dent Assoc. 1984 Dec;109(6):920-4. doi: 10.14219/jada.archive.1984.0246. No abstract available.
- Results publication: PubMed 31464823Berends SE, Bloem K, de Vries A, Schaap T, Rispens T, Strik AS, Talwar R, Lowenberg M, D'Haens GR, Mathot RA. Monitoring of Adalimumab Concentrations at Home in Patients with Inflammatory Bowel Disease Using Dried Blood Samples. Ther Drug Monit. 2020 Apr;42(2):289-294. doi: 10.1097/FTD.0000000000000686.
- Results publication: PubMed 32868447Dearlove B, Lewitus E, Bai H, Li Y, Reeves DB, Joyce MG, Scott PT, Amare MF, Vasan S, Michael NL, Modjarrad K, Rolland M. A SARS-CoV-2 vaccine candidate would likely match all currently circulating variants. Proc Natl Acad Sci U S A. 2020 Sep 22;117(38):23652-23662. doi: 10.1073/pnas.2008281117. Epub 2020 Aug 31.
- Results publication: PubMed 33340043ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314.
- Results publication: PubMed 32848205Gansevoort RT, Hilbrands LB. CKD is a key risk factor for COVID-19 mortality. Nat Rev Nephrol. 2020 Dec;16(12):705-706. doi: 10.1038/s41581-020-00349-4.
- Results publicationGezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020; publicatienr. 2020/23
- Results publication: PubMed 33151337Hilbrands LB, Duivenvoorden R, Vart P, Franssen CFM, Hemmelder MH, Jager KJ, Kieneker LM, Noordzij M, Pena MJ, Vries H, Arroyo D, Covic A, Crespo M, Goffin E, Islam M, Massy ZA, Montero N, Oliveira JP, Roca Munoz A, Sanchez JE, Sridharan S, Winzeler R, Gansevoort RT; ERACODA Collaborators. COVID-19-related mortality in kidney transplant and dialysis patients: results of the ERACODA collaboration. Nephrol Dial Transplant. 2020 Nov 1;35(11):1973-1983. doi: 10.1093/ndt/gfaa261.
- Results publication: PubMed 33125914Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021 Feb;21(2):e26-e35. doi: 10.1016/S1473-3099(20)30773-8. Epub 2020 Oct 27.
- Results publication: PubMed 21672157Katerinis I, Hadaya K, Duquesnoy R, Ferrari-Lacraz S, Meier S, van Delden C, Martin PY, Siegrist CA, Villard J. De novo anti-HLA antibody after pandemic H1N1 and seasonal influenza immunization in kidney transplant recipients. Am J Transplant. 2011 Aug;11(8):1727-33. doi: 10.1111/j.1600-6143.2011.03604.x. Epub 2011 Jun 14.
- Results publication: PubMed 25072119Kotton CN. Immunization after kidney transplantation-what is necessary and what is safe? Nat Rev Nephrol. 2014 Oct;10(10):555-62. doi: 10.1038/nrneph.2014.122. Epub 2014 Jul 29.
- 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.
Jan-Stephan F Sanders, MD PhD study director
University Medical Center Groningen
Marc H Hemmelder, MD PhD principal investigator
Maastricht University Medical Center
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 Covid19 and SARS-CoV Infection, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 4 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 18 Mar 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 incidence of COVID-19 (time frame: two years after SARS-CoV-2 vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841785, which also lists 22 linked publications.
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 18 Mar 2024.