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Status unknownNCT04743947Updated Jan 10, 2022

Vaccination Against COVID-19 in Chronic Kidney Disease

An observational study in Chronic Kidney Disease Stage 5 on Dialysis, Chronic Kidney Disease Stage 5 With Transplant and Vaccine Response Impaired, sponsored by Heinrich-Heine University, Duesseldorf. Status unknown at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Heinrich-Heine University, Duesseldorf · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.

Browse Heinrich-Heine University, Duesseldorf studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

- non-capable of giving consent

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

  • OtherNo intervention; observational study

    no intervention

06

What researchers measure

Primary outcomes

  1. SARS-CoV-2- antibody- titer

    SARS-CoV-2- antibody- titer after vaccine

    Time frame: 2 years

07

Study locations

5 of 5 sites recruiting
  • MVZ DaVita Rhein-Ruhr
    Düsseldorf, 40210, Germany
    • Gerd Hetzel, Prof. MD · Contact · Gerd.Hetzel@davita.com · 0211 16797-30
    • Lea Weiland · Sub investigator
    • Gerd Hetzel, Prof. MD · Principal investigator
    • Seher Küçükköylü, MD · Principal investigator
    Recruiting
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
    Düsseldorf, 40225, Germany
    • Lars Christian Rump, Prof. MD · Contact · christian.rump@med.uni-duesseldorf.de · 0211 876696-0
    • Johannes Stegbauer, MD · Sub investigator
    • Thilo Kolb, MD · Sub investigator
    • Lars Christian Rump, Prof. MD · Principal investigator
    Recruiting
  • University Hospital Düsseldorf, Heinrich Heine University
    Düsseldorf, 40225, Germany
    • Johannes Stegbauer, MD · Contact · johannes.stegbauer@med.uni-duesseldorf.de · +492118117502
    • Johannes Stegbauer, MD · Principal investigator
    • Thilo Kolb, MD · Sub investigator
    • Lars C Rump, MD · Sub investigator
    Recruiting
  • Nephrocare Mettmann
    Mettmann, 40822, Germany
    Recruiting
  • Hospital Solingen
    Solingen, 42653, Germany
    Recruiting
08

References and documents

Publications

  • Kolb T, Fischer S, Muller L, Lubke N, Hillebrandt J, Andree M, Schmitz M, Schmidt C, Kucukkoylu S, Koster L, Kittel M, Weiland L, Dreyling KW, Hetzel G, Adams O, Schaal H, Ivens K, Rump LC, Timm J, Stegbauer J. Impaired Immune Response to SARS-CoV-2 Vaccination in Dialysis Patients and in Kidney Transplant Recipients. Kidney360. 2021 Jul 13;2(9):1491-1498. doi: 10.34067/KID.0003512021. eCollection 2021 Sep 30. PubMed 35373105 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2020 (actual). Primary completion is estimated for Dec 2024, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2021
First posted
Feb 8, 2021
StartActual
Dec 21, 2020
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2025
Last update
Jan 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04743947
Lead sponsor
Heinrich-Heine University, Duesseldorf
Responsible party
PD Dr. med. Johannes Stegbauer (Assistant Professor, Heinrich-Heine University, Duesseldorf) — Principal investigator
First posted
Feb 8, 2021
Start date
Dec 21, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 10, 2022

Study contacts

Johannes Stegbauer, MD
Contact
johannes.stegbauer@med.uni-duesseldorf.de
+492118117502
Claudia Schmidt, PhD
Contact
claudia.schmidt@med.uni-duesseldorf.de
+492118108074

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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