Vaccination Against COVID-19 in Chronic Kidney Disease

Heinrich-Heine University, Duesseldorf

Status: Enrolling

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

Treatments: Other: No intervention; observational study

Study type: Observational

Funder types: Other

Identifiers

NCT04743947

2020-1237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• non-capable of giving consent

Trial design

400 participants in 3 patient groups

Patients with kidney failure receiving dialysis

Description:

Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in dialysis patients (hemodialysis or peritoneal dialysis).

Treatment:

Other: No intervention; observational study

Kidney transplant patients

Description:

Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in kidney transplant patients.

Treatment:

Other: No intervention; observational study

age-matched controls in non-dialysis, non-kidney transplant patients

Description:

Historical cohort of aged matched non-dialysis and non-kidney transplanted patients who received a SARS-CoV-2 vaccination.

Treatment:

Other: No intervention; observational study