Vaccination Against COVID-19 in Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease Stage 5 With TransplantChronic Kidney Disease Stage 5 on DialysisVaccine 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
- receiving dialysis (hemodialysis or peritoneal dialysis)
- capable of giving consent
- age 18 or older
- non-capable of giving consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SARS-CoV-2- antibody- titer 2 years SARS-CoV-2- antibody- titer after vaccine
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
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, GermanyGerd Hetzel, Prof. MDPrincipal InvestigatorLea WeilandSub InvestigatorSeher Küçükköylü, MDPrincipal Investigator