COVID-19: Determination of effect of COVID vaccination on immunity of hemodialysis patients

Phase 1

• Conditions: hemodialysis patientshemodialysis patients with comorbidities; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-000930-32-BE
• Lead Sponsor: AZ Sint-Jan Brugge-Oostende AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-04
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

1. Consecutive series of hemodialysis patients receiving Covid-19 RNA
vaccine. A target of at least 100 patients is envisioned. Minimum age for
inclusion is 18 years.
2. at least thirty healthy volunteers receiving Covid-19 RNA vaccine.
Minimum age for inclusion is 18 years. Individuals with immune
disorders cannot participate.
3. at least thirty patients older than 50 years with at least 1
comorbidity (such as heart failure, diabetes, COPD, liver cirrhosis,....),
but no chronic renal insufficiency. Minimum age for inclusion is 18 years.
Only patients who receive vaccine on a voluntary basis will be included.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- patients younger than 18 years old
- patients who do not voluntarily ask for a COVID-vaccination
- patients not eligible according to abovementioned inclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified