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NCT04743947

Vaccination Against COVID-19 in Chronic Kidney Disease

Status unknown Last updated 10 January 2022
What this trial tests

trial testing No intervention; observational study in Chronic Kidney Disease Stage 5 on Dialysis in 400 participants. Status unknown.

Timeline
21 December 2020
Primary endpoint
31 December 2024
31 December 2025

Quick facts

Lead sponsorHeinrich-Heine University, Duesseldorf
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment400
Start date21 December 2020
Primary completion31 December 2024
Estimated completion31 December 2025
Sites5 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Heinrich-Heine University, Duesseldorf

Who can join

18 and older, any sex, with Chronic Kidney Disease Stage 5 on Dialysis or Chronic Kidney Disease Stage 5 With Transplant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, multi-center, observational study that will enroll patients receiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidney transplantation who will be vaccinated against COVID-19.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Intensity of mycophenolate mofetil treatment is associated with an impaired immune response to SARS-CoV-2 vaccination in kidney transplant recipients.
    Kantauskaite M, Müller L, Kolb T, Fischer S, et al · · 2022 · cited 112× · PMID 34551181 · DOI 10.1111/ajt.16851
  2. Impaired Immune Response to SARS-CoV-2 Vaccination in Dialysis Patients and in Kidney Transplant Recipients.
    Kolb T, Fischer S, Müller L, Lübke N, et al · · 2021 · cited 42× · PMID 35373105 · DOI 10.34067/kid.0003512021
  3. Immune response to third SARS-CoV-2 vaccination in seronegative kidney transplant recipients: Possible improvement by mycophenolate mofetil reduction.
    Kantauskaite M, Müller L, Hillebrandt J, Lamberti J, et al · · 2022 · cited 18× · PMID 35997031 · DOI 10.1111/ctr.14790
  4. SARS-CoV-2 vaccination in patients receiving kidney replacement therapies: where are we now with the protective immune response?
    Toapanta N, Bestard O, Soler MJ. · · 2021 · cited 5× · PMID 34289072 · DOI 10.1093/ndt/gfab227
  5. Comparison of immune responses to SARS-CoV-2 spike following Omicron infection or Omicron BA.4/5 vaccination in kidney transplant recipients.
    Tometten I, Brandt T, Schlotz M, Stumpf R, et al · · 2024 · cited 1× · PMID 39877366 · DOI 10.3389/fimmu.2024.1476294
  6. Immune response to third SARS-CoV-2 vaccination in seronegative kidney transplant recipients: possible improvement by mycophenolate mofetil reduction
    Kantauskaite M, Müller L, Hillebrandt J, Lamberti J, et al · · 2022 · DOI 10.1101/2022.01.18.22269420

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