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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04743947
Enrollment
400
Registered
2021-02-08
Start date
2020-12-21
Completion date
2025-12-31
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

SARS-CoV-2, vaccination, dialysis, kidney transplantation

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.

Interventions

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* receiving dialysis (hemodialysis or peritoneal dialysis) * capable of giving consent * age 18 or older

Exclusion criteria

\- non-capable of giving consent

Design outcomes

Primary

MeasureTime frameDescription
SARS-CoV-2- antibody- titer2 yearsSARS-CoV-2- antibody- titer after vaccine

Countries

Germany

Contacts

Primary ContactJohannes Stegbauer, MD
johannes.stegbauer@med.uni-duesseldorf.de+492118117502
Backup ContactClaudia Schmidt, PhD
claudia.schmidt@med.uni-duesseldorf.de+492118108074

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026