Vaccination Against COVID-19 in Chronic Kidney Disease

January 6, 2022 updated by: PD Dr. med. Johannes Stegbauer, Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Düsseldorf, Germany, 40210
        • Recruiting
        • MVZ DaVita Rhein-Ruhr
        • Contact:
        • Sub-Investigator:
          • Lea Weiland
        • Principal Investigator:
          • Gerd Hetzel, Prof. MD
        • Principal Investigator:
          • Seher Küçükköylü, MD
      • Düsseldorf, Germany, 40225
        • Recruiting
        • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
        • Contact:
        • Sub-Investigator:
          • Johannes Stegbauer, MD
        • Sub-Investigator:
          • Thilo Kolb, MD
        • Principal Investigator:
          • Lars Christian Rump, Prof. MD
      • Düsseldorf, Germany, 40225
        • Recruiting
        • University Hospital Düsseldorf, Heinrich Heine University
        • Contact:
        • Sub-Investigator:
          • Thilo Kolb, MD
        • Principal Investigator:
          • Johannes Stegbauer, MD
        • Sub-Investigator:
          • Lars C Rump, MD
      • Mettmann, Germany, 40822
        • Recruiting
        • Nephrocare Mettmann
        • Contact:
      • Solingen, Germany, 42653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are treated in a nephrology in- or out-patient clinic and how are willing to get a SARS-CoV-2 vaccination.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- non-capable of giving consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2- antibody- titer
Time Frame: 2 years
SARS-CoV-2- antibody- titer after vaccine
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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