Clinical trial NCT04562051: Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
Official title: Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplantation
HBV
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplantation from HBsAg+ donors to HBsAg- recipients

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).


Eligibility criteria: 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.

Primary outcomes:
measure: composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients
timeFrame: 2020.9-2025.10
Secondary outcomes:
measure: Graft loss
timeFrame: 2020.9-2025.10
measure: biopsy-confirmed acute rejection
timeFrame: 2020.9-2025.10
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Tao Lin
state: Sichuan
Study officials:
affiliation: Organ transplant center, Department of Urology, West China Hospital
name: Xianding Wang, MD
role: STUDY_DIRECTOR
affiliation: Organ Transplant Center, Department of Urology, West China Hospital
name: Turun Song, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organ Transplant Center, Department of Urology, West China Hospital
name: Yu Fan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organ Transplant Center, Department of Urology, West China Hospital
name: Zhongli Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organ Transplant Center, Department of Urology, West China Hospital
name: Saifu Yin, MB
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of USTC, University of Science and Technology of China
name: Hongtao Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Wenjun Shang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Honglan Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: