Vaccination Against COVID-19 in Chronic Kidney Disease

Vaccine Response Impaired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743947
• Other study ID #: 2020-1237
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Johannes Stegbauer, MD
• Phone: +492118117502
• Email: johannes.stegbauer[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• receiving dialysis (hemodialysis or peritoneal dialysis)

• capable of giving consent

• age 18 or older

Exclusion Criteria:

• non-capable of giving consent

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5 on Dialysis
• Chronic Kidney Disease Stage 5 With Transplant
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Vaccine Response Impaired

Intervention

Other:
• No intervention; observational study
no intervention

Locations

Country	Name	City	State
Germany	KfH Kuratorium für Dialyse und Nierentransplantation e.V.	Düsseldorf
Germany	MVZ DaVita Rhein-Ruhr	Düsseldorf
Germany	University Hospital Düsseldorf, Heinrich Heine University	Düsseldorf
Germany	Nephrocare Mettmann	Mettmann
Germany	Hospital Solingen	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2- antibody- titer	SARS-CoV-2- antibody- titer after vaccine	2 years