Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
NCT ID: NCT04562051
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2020-09-10
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Tao Lin
Director
Principal Investigators
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Xianding Wang, MD
Role: STUDY_DIRECTOR
Organ transplant center, Department of Urology, West China Hospital
Turun Song, MD
Role: PRINCIPAL_INVESTIGATOR
Organ Transplant Center, Department of Urology, West China Hospital
Yu Fan, MD
Role: PRINCIPAL_INVESTIGATOR
Organ Transplant Center, Department of Urology, West China Hospital
Zhongli Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Organ Transplant Center, Department of Urology, West China Hospital
Saifu Yin, MB
Role: PRINCIPAL_INVESTIGATOR
Organ Transplant Center, Department of Urology, West China Hospital
Hongtao Liu, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of USTC, University of Science and Technology of China
Wenjun Shang, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Honglan Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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Tao Lin
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WestChina-KT
Identifier Type: -
Identifier Source: org_study_id