Trials / Unknown
UnknownNCT04743947
Vaccination Against COVID-19 in Chronic Kidney Disease
Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Heinrich-Heine University, Duesseldorf · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Chronic Kidney Disease Stage 5 on Dialysis
- Chronic Kidney Disease Stage 5 With Transplant
- Vaccine Response Impaired
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention; observational study | no intervention |
Timeline
- Start date
- 2020-12-21
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2021-02-08
- Last updated
- 2022-01-10
Locations
5 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04743947. Inclusion in this directory is not an endorsement.