COVID-19, Hemodialysis
Conditions
Interventions
None listed
Sponsors
the Japanese Society for Dialysis Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Dialysis Group] Outpatients undergoing dialysis at facilities that responded to the open call for participation posted on the Japanese Society for Dialysis Therapy (JSDT) website and who provided informed consent to participate in this study (on a first-come, first-served basis). [Control Group] Non-dialysis individuals who provided informed consent to participate (on a first-come, first-served basis), including patients attending hospitals or clinics affiliated with the JSDT, their family members, staff of these facilities, and staff or residents of affiliated nursing homes (with consent obtained from both the individual and their family, as applicable). Additionally, participants in both groups must be individuals who plan to receive the Pfizer-BioNTech COVID-19 vaccine (BNT162b2), have not yet received any doses at the time of consent, and are willing to complete all seven study visits over the course of one year.
Exclusion criteria
Exclusion criteria: [Control Group] Individuals will be excluded if they have an eGFR <45 mL/min/1.73 m2, have been diagnosed with nephrotic syndrome, have a history of cancer treatment within the past year, or are receiving steroids or immunosuppressive therapy. [Dialysis Group] Individuals will be excluded if they have a history of cancer treatment within the past year or are receiving steroids or immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 antibody titers will be measured using serum samples collected at the following time points: before the first vaccination, before the second vaccination, 2 weeks after the second vaccination, 3 months after the second vaccination, 6 months after the second vaccination, 1 month after the third vaccination, and 3 months after the third vaccination. | — |
Countries
Japan
Contacts
Public ContactAyumi Yoshifuji
Tokyo Saiseikai Central Hospital Nephrology
Outcome results
None listed