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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tao Lin
RECRUITING
Chengdu
Contact Information
Primary
Tao Lin, PhD
kidney5@163.com
+8618980602093
Time Frame
Start Date: 2020-09-10
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 100
Treatments
stratified prophylaxis group
The process of stratified prophylaxis was as follows. 1) If the recipient's HBsAb level is more than 100 IU/L and the donor is HBV DNA-, the recipient will not receive any preventive measures; 2) If the recipient's HBsAb is more than 100 IU/L and the donor is HBV DNA+, the recipient receives antiviral treatment for 1 month; 3) If the recipient's HBsAb is between 10 and 100 IU/L, the recipient is treated with single dose HBIG and antiviral treatment for 1 month regardless of the donor's HBV DNA status; 4) If the recipient's HBsAb is less than 10 IU/L, the recipient will receive single dose HBIG and antiviral treatment for 1 month regardless of the donor's HBV DNA status.
Routine prophylaxis group
Transplant centers adopted routine prophylaxis based on clinical experience
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov