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Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients

Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients

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Phase N/A

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Overview

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 HBsAgrecipients. 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 Criteria:

  1. patients diagnosed with end-stage renal diseases and suitable for living kidney transplantation;
  2. HBsAg+ donor was the only donor;
  3. age and sex of donors and recipients were unrestricted;
  4. ABO compatible or incompatible between the donor and recipient;
  5. The living donor voluntarily donates one of their kidneys to the recipient free of charge;
  6. The donor and recipient can understand the purpose and risk of living KT and sign informed consent;
  7. Ethics committee approved.

Exclusion Criteria:

  1. 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;
  2. positive complement-dependent cytotoxicity cross-match test;
  3. combined HCV or HIV infection in the donor or recipient;
  4. diagnosed with malignancy or had a history of malignancy in the past 5 years;
  5. non-kidney transplantation history.

Study details
    Kidney Transplantation
    HBV

NCT04562051

West China Hospital

27 January 2024

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