Clinical trial NCT04743947: Vaccination Against COVID-19 in Chronic Kidney Disease
Official title: Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease Stage 5 on Dialysis
Chronic Kidney Disease Stage 5 With Transplant
Vaccine Response Impaired
Keywords: SARS-CoV-2
vaccination
dialysis
kidney transplantation
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are treated in a nephrology in- or out-patient clinic and how are willing to get a SARS-CoV-2 vaccination.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* receiving dialysis (hemodialysis or peritoneal dialysis)
* capable of giving consent
* age 18 or older

Exclusion Criteria:

- non-capable of giving consent

Primary outcomes:
measure: SARS-CoV-2- antibody- titer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: MVZ DaVita Rhein-Ruhr
city: Düsseldorf
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf, Heinrich Heine University
city: Mettmann
country: Germany
facility: Nephrocare Mettmann
city: Solingen
country: Germany
facility: Hospital Solingen
Study officials:
References:
citation: Kolb T, Fischer S, Muller L, Lubke N, Hillebrandt J, Andree M, Schmitz M, Schmidt C, Kucukkoylu S, Koster L, Kittel M, Weiland L, Dreyling KW, Hetzel G, Adams O, Schaal H, Ivens K, Rump LC, Timm J, Stegbauer J. Impaired Immune Response to SARS-CoV-2 Vaccination in Dialysis Patients and in Kidney Transplant Recipients. Kidney360. 2021 Jul 13;2(9):1491-1498. doi: 10.34067/KID.0003512021. eCollection 2021 Sep 30.