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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562051
• Other study ID #: WestChina-KT
• Status: Recruiting
• Start date: September 10, 2020
• Est. completion date: June 1, 2026

Study information

• Verified date: November 2023
• Source: West China Hospital
• Contact: Tao Lin, PhD
• Phone: +8618980602093
• Email: kidney5[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• HBV
• Kidney Transplantation

Intervention

Other:
• prophylaxis regimen
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

Country	Name	City	State
China	Tao Lin	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients	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.	2020.9-2025.10
Secondary	Graft loss	Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min.	2020.9-2025.10
Secondary	biopsy-confirmed acute rejection	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.	2020.9-2025.10