Patients with chronic kidney failure prior to living-donor kidney transplantation Prior to living-donor kidney transplantation, Vaccination, Hepatitis B
Conditions
Interventions
Accelerated HBV vaccination schedule
Sponsors
Hanai Shogo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients from whom written informed consent was obtained of their own free will after receiving a sufficient explanation and demonstrating adequate understanding prior to participation in this study. 2. Adult patients aged 18 years or older at the time of consent. 3. Patients awaiting living-donor kidney transplantation. 4. Patients who are negative for hepatitis B surface antibody (anti-HBs). 5. Patients with no prior history of hepatitis B vaccination.
Exclusion criteria
Exclusion criteria: 1. Patients scheduled to receive rituximab within 34 days. 2. Patients scheduled to undergo organ transplantation within 34 days. 3. Patients who are positive for hepatitis B surface antigen (HBsAg). 4. Patients for whom at least six months are anticipated before the scheduled date of transplantation. 5. Patients who have received rituximab within the past six months. 6. Patients who have experienced severe adverse events related to hepatitis B vaccination. 7. Patients currently participating in another interventional study that may interfere with the evaluation of this study. 8. Patients deemed inappropriate for inclusion in the study by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate of anti-HBs prior to transplantation (or prior to rituximab administration in patients receiving rituximab) | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs seroconversion rate four weeks after the third vaccine dose Anti-HBs seroconversion rate four weeks after the fourth vaccine dose Distribution of anti-HBs antibody titers at the above time points Number of cases with serious adverse events, systemic adverse reactions, and local adverse reactions | — |
Contacts
Public ContactShogo Hanai
Fujita Health University Hospital
Outcome results
None listed