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

NCT04562051 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-11-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xianding Wang, MD · Organ transplant center, Department of Urology, West China Hospital

  • Turun Song, MD · Organ Transplant Center, Department of Urology, West China Hospital

  • Yu Fan, MD · Organ Transplant Center, Department of Urology, West China Hospital

  • Zhongli Huang, MD · Organ Transplant Center, Department of Urology, West China Hospital

  • Saifu Yin, MB · Organ Transplant Center, Department of Urology, West China Hospital

  • Hongtao Liu, MD · The First Affiliated Hospital of USTC, University of Science and Technology of China

  • Wenjun Shang, MD · The First Affiliated Hospital of Zhengzhou University

  • Honglan Zhou, MD · The First Hospital of Jilin University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2025-12-01
Completion
2026-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562051 on ClinicalTrials.gov