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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stratified prophylaxis group | The process of stratified prophylaxis was as follows. 1) If the recipient's HBsAb level is more than 100 IU/L and the donor is HBV DNA-, the recipient will not receive any preventive measures; 2) If the recipient's HBsAb is more than 100 IU/L and the donor is HBV DNA+, the recipient receives antiviral treatment for 1 month; 3) If the recipient's HBsAb is between 10 and 100 IU/L, the recipient is treated with single dose HBIG and antiviral treatment for 1 month regardless of the donor's HBV DNA status; 4) If the recipient's HBsAb is less than 10 IU/L, the recipient will receive single dose HBIG and antiviral treatment for 1 month regardless of the donor's HBV DNA status. |
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| Routine prophylaxis group | Transplant centers adopted routine prophylaxis based on clinical experience |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prophylaxis regimen | Other | All recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience |
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients | The primary outcome is the incidence of prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients, which is a composite endpoint. The composite outcome includes HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipients. Liver function damage is defined as postoperative abnormal liver dysfunction (ALT > 60IU/L for females, and >75 IU/L for males; or total bilirubin > 34 umol/L); or postoperative ultrasonography reported hepatic cirrhosis in the recipient. | 2020.9-2025.10 |
| Measure | Description | Time Frame |
|---|---|---|
| Graft loss | Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min. | 2020.9-2025.10 |
| biopsy-confirmed acute rejection | biopsy-confirmed acute rejection was diagnosed clinically based on a significant increase in serum creatinine levels of 50% or more within 3 days, which was not explained by other reasons and confirmed by biopsy. |
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Inclusion Criteria:
Exclusion Criteria:
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Kidney transplantation from HBsAg+ donors to HBsAg- recipients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Lin, PhD | Contact | +8618980602093 | kidney5@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianding Wang, MD | Organ transplant center, Department of Urology, West China Hospital | Study Director |
| Turun Song, MD | Organ Transplant Center, Department of Urology, West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tao Lin | Recruiting | Chengdu | Sichuan | 610041 | China |
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| 2020.9-2025.10 |
| Yu Fan, MD | Organ Transplant Center, Department of Urology, West China Hospital | Principal Investigator |
| Zhongli Huang, MD | Organ Transplant Center, Department of Urology, West China Hospital | Principal Investigator |
| Saifu Yin, MB | Organ Transplant Center, Department of Urology, West China Hospital | Principal Investigator |
| Hongtao Liu, MD | The First Affiliated Hospital of USTC, University of Science and Technology of China | Principal Investigator |
| Wenjun Shang, MD | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Honglan Zhou, MD | The First Hospital of Jilin University | Principal Investigator |