Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04743947
Other study ID # 2020-1237
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2020
Est. completion date December 31, 2025

Study information

Verified date January 2022
Source Heinrich-Heine University, Duesseldorf
Contact Johannes Stegbauer, MD
Phone +492118117502
Email johannes.stegbauer@med.uni-duesseldorf.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
No intervention; observational study
no intervention

Locations

Country Name City State
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 Hospital Solingen Solingen

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary SARS-CoV-2- antibody- titer SARS-CoV-2- antibody- titer after vaccine 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05060991 - Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients Phase 4
Active, not recruiting NCT01446978 - Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs Phase 2
Completed NCT03855176 - Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients Phase 4
Not yet recruiting NCT05923970 - Is a Third Dose of MMRV Vaccine Beneficial for the Adult Population in Alberta?
Recruiting NCT05019248 - Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
Completed NCT03467074 - Role of Interferon-λ and Vaccine Response
Completed NCT05124509 - Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant
Completed NCT05791851 - Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders
Completed NCT05030974 - RECOVAC Repeated Vaccination Study Phase 4
Completed NCT03930017 - Pregnancy, Arsenic and Immune Response
Completed NCT05116748 - COVID19 Vaccine in SOT Adult Recipients
Recruiting NCT06148025 - Antibiotics and Vaccine Immune Responses Study Phase 4
Completed NCT03368495 - Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines Phase 4
Completed NCT04059991 - Antibodies in Repeated Influenza Vaccination (ARIVA) Study
Completed NCT04915820 - Iron and COVID-19 Vaccine Response N/A
Completed NCT04912661 - Iron and Vaccine Response N/A
Completed NCT04885907 - Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients Phase 4
Completed NCT03588013 - Study of Environmental Enteropathy and Malnutrition in Pakistan N/A
Completed NCT04936997 - Immune Response to the COVID-19 Vaccine Early Phase 1
Completed NCT03996538 - Vaccination Efficacy With Metformin in Older Adults Phase 1