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

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).

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation; HBV
• Intervention / Treatment: Other: prophylaxis regimen

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Tao Lin, PhD; Phone Number: +8618980602093; Email: kidney5@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Tao Lin
      • Contact: Tao Lin, MD; Phone Number: +8618980602093; Email: kidney5@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Kidney transplantation from HBsAg+ donors to HBsAg- recipients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
Routine prophylaxis group; Transplant centers adopted routine prophylaxis based on clinical experience	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Xianding Wang, MD, Organ Transplant Center, Department of Urology, West China Hospital; Principal Investigator: Turun Song, MD, Organ Transplant Center, Department of Urology, West China Hospital; Principal Investigator: Yu Fan, MD, Organ Transplant Center, Department of Urology, West China Hospital; Principal Investigator: Zhongli Huang, MD, Organ Transplant Center, Department of Urology, West China Hospital; Principal Investigator: Saifu Yin, MB, Organ Transplant Center, Department of Urology, West China Hospital; Principal Investigator: Hongtao Liu, MD, The First Affiliated Hospital of USTC, University of Science and Technology of China; Principal Investigator: Wenjun Shang, MD, The First Affiliated Hospital of Zhengzhou University; Principal Investigator: Honglan Zhou, MD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: WestChina-KT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No