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Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients
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.
Patients on dialysis and kidney transplant patients infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) have an increased risk to develop a more severe course of disease or die from COVID-19 (coronavirus disease 2019). SARS-CoV-2 vaccination can increase protection against COVID-19. Kidney transplant patients and patients requiring dialysis suffer from an acquired immune deficiency. Due to the dysfunctional immune response, the general vaccine response in dialysis patients and kidney transplant patients is in many cases insufficient. Until now, the vaccination response in dialysis patients and kidney-transplanted patients is unpredictable. Verification of vaccine response can provide important information on how to treat and protect these patients from a COVID-19. Therefore, there is a medical need to monitor vaccine protection after SARS-CoV-2 vaccination in clinical practice. In this observational study, data of the SARS-CoV-2 vaccination response collected in clinical routine will be analyzed from these patients. Based on this observational study, the investigators aim to get first evidence whether and to what extent vaccination against COVID-19 causes a vaccine response in immunocompromised patients with kidney disease.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
MVZ DaVita Rhein-Ruhr
Düsseldorf, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Düsseldorf, Germany
University Hospital Düsseldorf, Heinrich Heine University
Düsseldorf, Germany
Nephrocare Mettmann
Mettmann, Germany
Hospital Solingen
Solingen, Germany
Start Date
December 21, 2020
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2025
Last Updated
January 10, 2022
400
ESTIMATED participants
No intervention; observational study
OTHER
Lead Sponsor
Heinrich-Heine University, Duesseldorf
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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