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).
Study Type
OBSERVATIONAL
Enrollment
100
All recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience
Tao Lin
Chengdu, Sichuan, China
RECRUITINGcomposite 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.
Time frame: 2020.9-2025.10
Graft loss
Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of \<15 ml/min.
Time frame: 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.
Time frame: 2020.9-2025.10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.