Kidney TransplantationNCT04562051
Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
An observational study of Kidney Transplantation and HBV, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation, HBV
- What is being tested?
- prophylaxis regimen
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to 1 Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney transplantation from HBsAg+ donors to HBsAg- recipients
Who may be able to join
- patients diagnosed with end-stage renal diseases and suitable for living kidney transplantation;
- HBsAg+ donor was the only donor;
- age and sex of donors and recipients were unrestricted;
- ABO compatible or incompatible between the donor and recipient;
- The living donor voluntarily donates one of their kidneys to the recipient free of charge;
- The donor and recipient can understand the purpose and risk of living KT and sign informed consent;
- Ethics committee approved.
Who cannot join
- 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;
- positive complement-dependent cytotoxicity cross-match test;
- combined HCV or HIV infection in the donor or recipient;
- diagnosed with malignancy or had a history of malignancy in the past 5 years;
- non-kidney transplantation history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tao Lin
Chengdu, Sichuan, 610041
Tao Lin, MD, +8618980602093, kidney5@163.com
About this study
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
- Being tested
- prophylaxis regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylaxis regimenOther
All recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: prophylaxis regimen | |
| Routine prophylaxis group | Transplant centers adopted routine prophylaxis based on clinical experience Receives: Other: prophylaxis regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients
The primary outcome is the incidence of prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients, which is a composite endpoint. The composite outcome includes HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipients. Liver function damage is defined as postoperative abnormal liver dysfunction (ALT > 60IU/L for females, and >75 IU/L for males; or total bilirubin > 34 umol/L); or postoperative ultrasonography reported hepatic cirrhosis in the recipient.
Measured: 2020.9-2025.10
Secondary outcomes (2)
Graft loss
Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min.
Measured: 2020.9-2025.10
biopsy-confirmed acute rejection
biopsy-confirmed acute rejection was diagnosed clinically based on a significant increase in serum creatinine levels of 50% or more within 3 days, which was not explained by other reasons and confirmed by biopsy.
Measured: 2020.9-2025.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start10 Sep 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Lin, West China Hospital
- Investigators
- Xianding Wang, MD, Study director, Organ transplant center, Department of Urology, West China HospitalTurun Song, MD, Principal investigator, Organ Transplant Center, Department of Urology, West China HospitalYu Fan, MD, Principal investigator, Organ Transplant Center, Department of Urology, West China HospitalZhongli Huang, MD, Principal investigator, Organ Transplant Center, Department of Urology, West China HospitalSaifu Yin, MB, Principal investigator, Organ Transplant Center, Department of Urology, West China HospitalHongtao Liu, MD, Principal investigator, The First Affiliated Hospital of USTC, University of Science and Technology of ChinaWenjun Shang, MD, Principal investigator, The First Affiliated Hospital of Zhengzhou UniversityHonglan Zhou, MD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562051
- Sponsor's protocol ID
- WestChina-KT
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
- ClinicalTrials.gov ID
- NCT04562051
- Acronym / sponsor ID
- WestChina-KT
- Conditions
- Kidney Transplantation, HBV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stratified prophylaxis group | – | Other: prophylaxis regimenThe 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. |
| Routine prophylaxis group | – | Other: prophylaxis regimenTransplant centers adopted routine prophylaxis based on clinical experience |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplantation from HBsAg+ donors to HBsAg- recipients
Key inclusion criteria (7 listed)
- patients diagnosed with end-stage renal diseases and suitable for living kidney transplantation;
- HBsAg+ donor was the only donor;
- age and sex of donors and recipients were unrestricted;
- ABO compatible or incompatible between the donor and recipient;
- The living donor voluntarily donates one of their kidneys to the recipient free of charge;
Key exclusion criteria (5 listed)
- 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;
- positive complement-dependent cytotoxicity cross-match test;
- combined HCV or HIV infection in the donor or recipient;
- diagnosed with malignancy or had a history of malignancy in the past 5 years;
- non-kidney transplantation history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prophylaxis regimenAll recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience | Other | Routine prophylaxis group, stratified prophylaxis group |
Primary outcome
composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients
Time frame: 2020.9-2025.10
The primary outcome is the incidence of prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients, which is a composite endpoint. The composite outcome includes HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipients. Liver function damage is defined as postoperative abnormal liver dysfunction (ALT > 60IU/L for females, and >75 IU/L for males; or total bilirubin > 34 umol/L); or postoperative ultrasonography reported hepatic cirrhosis in the recipient.
2 secondary outcomes
Graft loss
Time frame: 2020.9-2025.10
biopsy-confirmed acute rejection
Time frame: 2020.9-2025.10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianding Wang, MD study director
Organ transplant center, Department of Urology, West China Hospital
Turun Song, MD principal investigator
Organ Transplant Center, Department of Urology, West China Hospital
Yu Fan, MD principal investigator
Organ Transplant Center, Department of Urology, West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and HBV, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Lin, PhD (+8618980602093, kidney5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients (time frame: 2020.9-2025.10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.