Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
West China Hospital
100 participants
Sep 10, 2020
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria5
- 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.
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Interventions
All recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04562051