Comparing two approaches to prevent HBV transmission in kidney transplants from HBsAg+ donors
Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
This study is testing whether a new prevention method can stop the spread of hepatitis B in kidney transplant patients who receive organs from donors with the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT04562051 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, observational study aims to evaluate the efficacy and safety of a stratified prophylaxis regimen versus routine prophylaxis in living kidney transplantation from HBsAg+ donors to HBsAg- recipients. The study will follow participants for two years post-transplantation, focusing on preventing HBV transmission and assessing various clinical outcomes related to liver function. The primary outcome measures include the incidence of HBV transmission and related complications in recipients.
Who should consider this trial
Good fit: Ideal candidates include patients with end-stage renal disease who are suitable for living kidney transplantation from HBsAg+ donors.
Not a fit: Patients with preoperative liver dysfunction, combined HCV or HIV infection, or a history of malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of HBV transmission in kidney transplant recipients, improving patient safety and outcomes.
How similar studies have performed: While there have been studies on HBV transmission in kidney transplantation, this specific stratified approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichuan
- Tao Lin — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Turun Song, MD — Organ Transplant Center, Department of Urology, West China Hospital
- Study coordinator: Tao Lin, PhD
- Email: kidney5@163.com
- Phone: +8618980602093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.