Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with end-stage renal diseases and suitable for living kidney transplantation;
- •HBsAg+ donor was the only donor;
- •age and sex of donors and recipients were unrestricted;
- •ABO compatible or incompatible between the donor and recipient;
- •The living donor voluntarily donates one of their kidneys to the recipient free of charge;
- •The donor and recipient can understand the purpose and risk of living KT and sign informed consent;
- •Ethics committee approved.
排除标准
- •preoperative abnormal liver dysfunction in the donor or recipient (ALT > 60IU/L for females, and >75 IU/L for males; or total bilirubin > 34 umol/L); or preoperative ultrasonography in the donor or recipient reported hepatic cirrhosis;
- •positive complement-dependent cytotoxicity cross-match test;
- •combined HCV or HIV infection in the donor or recipient;
- •diagnosed with malignancy or had a history of malignancy in the past 5 years;
- •non-kidney transplantation history.
结局指标
主要结局
composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients
时间窗: 2020.9-2025.10
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.
次要结局
- biopsy-confirmed acute rejection(2020.9-2025.10)
- Graft loss(2020.9-2025.10)