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

Sponsor
West China Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04562051
Collaborator
(none)
100
1
68.7
1.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: prophylaxis regimen

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
Actual Study Start Date :
Sep 10, 2020
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tao Lin Chengdu Sichuan China 610041

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tao Lin, Director, West China Hospital
ClinicalTrials.gov Identifier:
NCT04562051
Other Study ID Numbers:
  • WestChina-KT
First Posted:
Sep 24, 2020
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 22, 2021