Immune response after covid-19 vaccination in patients with renal failure stadium 4 or 5 .
- Conditions
- Renal failure stage 4 and 5.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-000988-68-SE
- Lead Sponsor
- Region Stockholm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
- Adult 18-65 years old.
- Chronic renal failure stadium 4 or 5 with or without dialysis.
- The study patient has given her/his consent to participate in the study.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- Previous renal transplantation
- Concomitant medication with immune-modulating agent
- Current or previous known covid-19 infection at inclusion (i.e previous PCR positive for SARS-CoV-2 or previous detection of SARS-CoV-s antibodies).
Antibodies detected during screening for this study is not an exclusion criterion.
- Information in the Health declaration for covid-19 vaccination (17) which suggests that vaccination is inappropriate.
- Vaccinated or planned vaccination with other vaccine within the next 14 days that can not be rescheduled.
- Pregnancy
- Hypersensitivity for any substance in the vaccine
- Mental impairment, reluctance to participate or language difficulties which entail difficulties to understand the implication of the study
- Individual who is not considered appropriate for study participation due to any other reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method