Vaccination Against COVID-19 in Chronic Kidney Disease

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04743947
• Collaborator: (none)
• Enrollment: 400
• Locations: 5
• Anticipated Duration (Months): 60.3
• Patients Per Site: 80
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Stage 5 on Dialysis; Chronic Kidney Disease Stage 5 With Transplant; Vaccine Response Impaired	Other: No intervention; observational study

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

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients
• Actual Study Start Date: Dec 21, 2020
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. SARS-CoV-2- antibody- titer [2 years]

   SARS-CoV-2- antibody- titer after vaccine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• receiving dialysis (hemodialysis or peritoneal dialysis)

• capable of giving consent

• age 18 or older

Exclusion Criteria:

• non-capable of giving consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MVZ DaVita Rhein-Ruhr	Düsseldorf		Germany	40210
2	KfH Kuratorium für Dialyse und Nierentransplantation e.V.	Düsseldorf		Germany	40225
3	University Hospital Düsseldorf, Heinrich Heine University	Düsseldorf		Germany	40225
4	Nephrocare Mettmann	Mettmann		Germany	40822
5	Hospital Solingen	Solingen		Germany	42653

Sponsors and Collaborators

• Heinrich-Heine University, Duesseldorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PD Dr. med. Johannes Stegbauer, Assistant Professor, Heinrich-Heine University, Duesseldorf
• ClinicalTrials.gov Identifier: NCT04743947
• Other Study ID Numbers: 2020-1237
• First Posted: Feb 8, 2021
• Last Update Posted: Jan 10, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by PD Dr. med. Johannes Stegbauer, Assistant Professor, Heinrich-Heine University, Duesseldorf: SARS-CoV-2; vaccination; dialysis; kidney transplantation
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Study Results

No Results Posted as of Jan 10, 2022