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NCT04743947 Clinical Trial

Vaccination Against COVID-19 in Chronic Kidney Disease

Vaccine Response Impaired Clinical Trial

Official title:
Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04743947
Other study ID # 2020-1237
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2020
Est. completion date December 31, 2025

Study information
Verified date January 2022
Source Heinrich-Heine University, Duesseldorf
Contact Johannes Stegbauer, MD
Phone +492118117502
Email johannes.stegbauer@med.uni-duesseldorf.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - receiving dialysis (hemodialysis or peritoneal dialysis) - capable of giving consent - age 18 or older Exclusion Criteria: - non-capable of giving consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention; observational study
no intervention

Locations
Country Name City State
Germany KfH Kuratorium für Dialyse und Nierentransplantation e.V. Düsseldorf
Germany MVZ DaVita Rhein-Ruhr Düsseldorf
Germany University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
Germany Nephrocare Mettmann Mettmann
Germany Hospital Solingen Solingen

Sponsors (1)
Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary SARS-CoV-2- antibody- titer SARS-CoV-2- antibody- titer after vaccine 2 years
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