Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2020-12-21
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with kidney failure receiving dialysis
Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in dialysis patients (hemodialysis or peritoneal dialysis).
No intervention; observational study
no intervention
Kidney transplant patients
Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in kidney transplant patients.
No intervention; observational study
no intervention
age-matched controls in non-dialysis, non-kidney transplant patients
Historical cohort of aged matched non-dialysis and non-kidney transplanted patients who received a SARS-CoV-2 vaccination.
No intervention; observational study
no intervention
Interventions
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No intervention; observational study
no intervention
Eligibility Criteria
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Inclusion Criteria
* capable of giving consent
* age 18 or older
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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PD Dr. med. Johannes Stegbauer
Assistant Professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2020-1237
Identifier Type: -
Identifier Source: org_study_id
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