Trials / Recruiting
RecruitingNCT04562051
Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- West China Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, prospective, observational study to compare the efficacy and safety of stratified prophylaxis based on donors' and recipients' risk factors vs routine prophylaxis bases on clinical experience in living kidney transplantation from HBsAg+ donors to HBsAg- recipients. The follow-up period was 2 years after renal transplantation. The primary outcome was prevention failure of HBV transmission (any one of HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipient).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | prophylaxis regimen | All recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience |
Timeline
- Start date
- 2020-09-10
- Primary completion
- 2025-12-01
- Completion
- 2026-06-01
- First posted
- 2020-09-24
- Last updated
- 2023-11-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04562051. Inclusion in this directory is not an endorsement.