Vaccination Against COVID-19 in Chronic Kidney Disease

NCT04743947 | Unknown

• 1 other identifier: 2020-1237
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2- antibody- titer

  SARS-CoV-2- antibody- titer after vaccine

  2 years

Study Arms (3)

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

No intervention; observational study OTHER

no intervention

Kidney transplant patients; Patients with kidney failure receiving dialysis; age-matched controls in non-dialysis, non-kidney transplant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- non-capable of giving consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (5)

MVZ DaVita Rhein-Ruhr

Düsseldorf, 40210, Germany

RECRUITING

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Düsseldorf, 40225, Germany

RECRUITING

University Hospital Düsseldorf, Heinrich Heine University

Düsseldorf, 40225, Germany

RECRUITING

Nephrocare Mettmann

Mettmann, 40822, Germany

RECRUITING

Hospital Solingen

Solingen, 42653, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 35373105 DERIVED

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Johannes Stegbauer, MD

CONTACT

+492118117502; johannes.stegbauer@med.uni-duesseldorf.de

Claudia Schmidt, PhD

CONTACT

+492118108074; claudia.schmidt@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 8, 2021
• Study Start: December 21, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)