Actively Recruiting

All Genders
NCT04562051

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

Led by West China Hospital · Updated on 2023-11-29

100

Participants Needed

1

Research Sites

298 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with end-stage renal disease and suitable for living kidney transplantation
  • Donor is HBsAg positive and is the only donor
  • No age or sex restrictions for donors and recipients
  • Donor and recipient can be ABO compatible or incompatible
  • Living donor donates one kidney voluntarily and free of charge
  • Both donor and recipient understand the purpose and risks and sign informed consent
  • Study approved by ethics committee
Not Eligible

You will not qualify if you...

  • Donor or recipient has abnormal liver function before surgery (ALT > 60 IU/L for females, > 75 IU/L for males; or total bilirubin > 34 umol/L)
  • Donor or recipient has liver cirrhosis shown by ultrasound
  • Positive complement-dependent cytotoxicity cross-match test
  • Donor or recipient infected with HCV or HIV
  • Diagnosed with malignancy or history of malignancy within last 5 years
  • History of kidney transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tao Lin

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

T

Tao Lin, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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