Vaccination Against COVID-19 in Chronic Kidney Disease

Recruiting

• Conditions: Chronic Kidney Disease Stage 5 With Transplant; Chronic Kidney Disease Stage 5 on Dialysis; Vaccine Response Impaired
• Interventions: Other: No intervention; observational study

• Registration Number: NCT04743947
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2020-12-21
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-10
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• non-capable of giving consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
age-matched controls in non-dialysis, non-kidney transplant patients	No intervention; observational study	Historical cohort of aged matched non-dialysis and non-kidney transplanted patients who received a SARS-CoV-2 vaccination.
Kidney transplant patients	No intervention; observational study	Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in kidney transplant patients.
Patients with kidney failure receiving dialysis	No intervention; observational study	Analysis of data received from clinical practice about the SARS-CoV-2 vaccination response in dialysis patients (hemodialysis or peritoneal dialysis).

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2- antibody- titer	2 years	SARS-CoV-2- antibody- titer after vaccine

Trial Locations

Locations (5)

Hospital Solingen; 🇩🇪 Solingen, 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