Chronic Kidney Disease Stage 5 on DialysisNCT04743947
Vaccination Against COVID-19 in Chronic Kidney Disease
An observational study of Chronic Kidney Disease Stage 5 on Dialysis and Chronic Kidney Disease Stage 5 With Transplant, run by Heinrich-Heine University, Duesseldorf at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 5 on Dialysis, Chronic Kidney Disease Stage 5 With Transplant, Vaccine Response Impaired
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 5 sitesGermany
- Study dates
- 21 Dec 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- receiving dialysis (hemodialysis or peritoneal dialysis)
- capable of giving consent
- age 18 or older
Who cannot join
- non-capable of giving consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
MVZ DaVita Rhein-Ruhr
Düsseldorf, 40210
Gerd Hetzel, Prof. MD, 0211 16797-30, Gerd.Hetzel@davita.com
Lea Weiland
- Recruiting
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Düsseldorf, 40225
Lars Christian Rump, Prof. MD, 0211 876696-0, christian.rump@med.uni-duesseldorf.de
Johannes Stegbauer, MD
- Recruiting
University Hospital Düsseldorf, Heinrich Heine University
Düsseldorf, 40225
Johannes Stegbauer, MD, +492118117502, johannes.stegbauer@med.uni-duesseldorf.de
Johannes Stegbauer, MD
- Recruiting
Nephrocare Mettmann
Mettmann, 40822
Michael Koch, Prof. MD, 02051 4197-0, koch@dialyse-mettmann.de
- Recruiting
Hospital Solingen
Solingen, 42653
Michael Schmitz, MD, 0212-547-2418, schmitz.m@klinikumsolingen.de
About this study
Official title: 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.
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.
- Conditions
- Chronic Kidney Disease Stage 5 on Dialysis, Chronic Kidney Disease Stage 5 With Transplant, Vaccine Response Impaired
- Being tested
- No intervention; observational study
- Keywords
- SARS-CoV-2, vaccination, dialysis, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; observational studyOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: No intervention; observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2- antibody- titer
SARS-CoV-2- antibody- titer after vaccine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start21 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 5 on DialysisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Johannes Stegbauer, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743947
- Sponsor's protocol ID
- 2020-1237
- Status last verified
- Jan 2022
- First submitted
- 4 Feb 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT04743947
- Acronym / sponsor ID
- 2020-1237
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with kidney failure receiving dialysis | – | Other: No intervention; observational studyAnalysis of data received from clinical practice about the SARS-CoV-2 vaccination response in dialysis patients (hemodialysis or peritoneal dialysis). |
| Kidney transplant patients | – | Other: No intervention; observational studyAnalysis of data received from clinical practice about the SARS-CoV-2 vaccination response in kidney transplant patients. |
| age-matched controls in non-dialysis, non-kidney transplant patients | – | Other: No intervention; observational studyHistorical cohort of aged matched non-dialysis and non-kidney transplanted patients who received a SARS-CoV-2 vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- receiving dialysis (hemodialysis or peritoneal dialysis)
- capable of giving consent
- age 18 or older
Key exclusion criteria (1 listed)
- non-capable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; observational studyno intervention | Other | Kidney transplant patients, Patients with kidney failure receiving dialysis, age-matched controls in non-dialysis, non-kidney transplant patients |
Primary outcome
SARS-CoV-2- antibody- titer
Time frame: 2 years
SARS-CoV-2- antibody- titer after vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 35373105Kolb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Stage 5 on Dialysis and Chronic Kidney Disease Stage 5 With Transplant, run by Heinrich-Heine University, Duesseldorf at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Stegbauer, MD (+492118117502, johannes.stegbauer@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2- antibody- titer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.