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

Launched by WEST CHINA HOSPITAL · Sep 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the best way to prevent the spread of hepatitis B virus (HBV) during kidney transplants from donors who are positive for HBV (HBsAg+) to recipients who are negative (HBsAg-). Specifically, it compares two approaches: one that tailors prevention strategies based on the specific risk factors of both the donor and recipient, and another that uses a standard method based on previous experience. The trial will follow participants for two years to see how effective and safe these approaches are in stopping HBV from transmitting to the recipient.

To be eligible for this study, participants must have end-stage kidney disease and be suitable for a living kidney transplant from an HBsAg+ donor. Both donors and recipients can be of any age or gender, and they must be willing to donate or receive a kidney voluntarily. However, individuals with certain health conditions, like liver dysfunction or other infections, cannot participate. If you join, you can expect regular check-ups and monitoring to ensure your health and safety during the study period.

Gender

ALL

Eligibility criteria

• 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.