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Vaccination Against COVID-19 in Chronic Kidney Disease

Recruiting
Conditions
Chronic Kidney Disease Stage 5 With Transplant
Chronic Kidney Disease Stage 5 on Dialysis
Vaccine Response Impaired
Registration Number
NCT04743947
Lead Sponsor
Heinrich-Heine University, Duesseldorf
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
400
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
SARS-CoV-2- antibody- titer2 years

SARS-CoV-2- antibody- titer after vaccine

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (5)

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

MVZ DaVita Rhein-Ruhr
🇩🇪Düsseldorf, Germany
Gerd Hetzel, Prof. MD
Principal Investigator
Lea Weiland
Sub Investigator
Seher Küçükköylü, MD
Principal Investigator

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