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

Recruiting

• Conditions: HBV; Kidney Transplantation
• Interventions: Other: prophylaxis regimen

• Registration Number: NCT04562051
• Lead Sponsor: West China Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-10
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stratified prophylaxis group	prophylaxis regimen	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	prophylaxis regimen	Transplant centers adopted routine prophylaxis based on clinical experience

Primary Outcome Measures

Name	Time	Method
composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients	2020.9-2025.10	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.

Secondary Outcome Measures

Name	Time	Method
biopsy-confirmed acute rejection	2020.9-2025.10	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.
Graft loss	2020.9-2025.10	Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of \<15 ml/min.

Trial Locations

Locations (1)

Tao Lin; 🇨🇳 Chengdu, Sichuan, China