Vaccination Against COVID-19 in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients

Conditions
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Chronic Kidney Disease Stage 5 With Transplant, Chronic Kidney Disease Stage 5 on Dialysis, Vaccine Response Impaired

Intervention / Treatment
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* Other: No intervention; observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: receiving dialysis (hemodialysis or peritoneal dialysis) capable of giving consent age 18 or older Exclusion Criteria: - non-capable of giving consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with kidney failure receiving dialysis<br>Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in dialysis patients (hemodialysis or peritoneal dialysis). | Other: No intervention; observational study<br>* no intervention<br>|
| Kidney transplant patients<br>Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in kidney transplant patients. | Other: No intervention; observational study<br>* no intervention<br>|
| age-matched controls in non-dialysis, non-kidney transplant patients<br>Historical cohort of aged matched non-dialysis and non-kidney transplanted patients who received a SARS-CoV-2 vaccination. | Other: No intervention; observational study<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2- antibody- titer | SARS-CoV-2- antibody- titer after vaccine | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, vaccination, dialysis, kidney transplantation