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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Kidney transplant patients | Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in kidney transplant patients. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention; observational study | Other | no intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2- antibody- titer | SARS-CoV-2- antibody- titer after vaccine | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
- non-capable of giving consent
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Patients who are treated in a nephrology in- or out-patient clinic and how are willing to get a SARS-CoV-2 vaccination.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Stegbauer, MD | Contact | +492118117502 | johannes.stegbauer@med.uni-duesseldorf.de | |
| Claudia Schmidt, PhD | Contact | +492118108074 | claudia.schmidt@med.uni-duesseldorf.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MVZ DaVita Rhein-Ruhr | Recruiting | Düsseldorf | 40210 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35373105 | Derived | 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. |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Recruiting | Düsseldorf | 40225 | Germany |
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| University Hospital Düsseldorf, Heinrich Heine University | Recruiting | Düsseldorf | 40225 | Germany |
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| Nephrocare Mettmann | Recruiting | Mettmann | 40822 | Germany |
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| Hospital Solingen | Recruiting | Solingen | 42653 | Germany |
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