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

NCT04562051 | Recruiting DMC

• 1 other identifier: WestChina-KT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Transplantation; HBV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Graft loss

  2020.9-2025.10

• biopsy-confirmed acute rejection

  2020.9-2025.10

Study Arms (2)

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

Routine prophylaxis group

Transplant centers adopted routine prophylaxis based on clinical experience

Other: prophylaxis regimen

Interventions

prophylaxis regimen OTHER

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; stratified prophylaxis group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplantation from HBsAg+ donors to HBsAg- recipients

You may qualify if:

• 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.

You may not qualify if:

• 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;
• positive complement-dependent cytotoxicity cross-match test;
• combined HCV or HIV infection in the donor or recipient;
• diagnosed with malignancy or had a history of malignancy in the past 5 years;
• non-kidney transplantation history.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Tao Lin

Chengdu, Sichuan, 610041, China

RECRUITING

Study Officials

• Xianding Wang, MD

  Organ transplant center, Department of Urology, West China Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Lin, PhD

CONTACT

+8618980602093; kidney5@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 24, 2020
• Study Start: September 10, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)