HBsAg(+) Donor Kidney AllograftNCT02044588
Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients
An observational study of HBsAg(+) Donor Kidney Allograft and HBsAg(-) Donor Kidney Allograft, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To determine the safety of using kidney organ from hepatitis B surface antigen positive donor, the author conducted the single-center, prospective study of the use of these kidneys for recipients who have protective level of hepatitis B surface antibodies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBsAg(+) Donor Kidney Allograft, HBsAg(-) Donor Kidney Allograft
- What is being tested?
- HBsAg positive kidney allograft donor
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2000to Dec 2014
- How long will I take part?
- 10 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All kidney transplant recipients from January 1, 2000 until the present (upto year 2013) were prospective follow-up.
The inclusion criterion was:
- All kidney allograft recipients who received at least one month after transplantation.
- All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.
The exclusion criterion was:
- The recipients with positive hepatitis C virus antibody.
- The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
- The recipients those lost to follow-up.
Trial locations and contacts
1 site in 1 country.
Wiwat Chancharoenthana, MD, MSc contact
Thailand1 site, 1 recruiting
- Recruiting
Wiwat Chancharoenthana
Bangkok, Bangkok, 10330
Wiwat Chancharoenthana, MD, Msc, wiwatmd@hotmail.com
About this study
Official title: The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg
To determine the safety of using kidney organ from hepatitis B surface antigen positive donor, the author conducted the single-center, prospective study of the use of these kidneys for recipients who have protective level of hepatitis B surface antibodies.
Read the detailed description
The kidney transplant registry was conducted in KCMH since the year of 2000 until the present.
The inclusion criterion was:
- All kidney allograft recipients who received at least one month after transplantation.
- All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.
The exclusion criterion was:
- The recipients with positive hepatitis C virus antibody.
- The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
- The recipients those lost to follow-up.
Study group:
- The recipients who received kidney allograft from the HBsAg(+) donor.
Control group:
- The recipients who received kidney allograft from the HBsAg(-) donor.
According to the Thai Red Cross National Organ Donation and our institute's policy, the HBsAg(+) kidney allografts were distributed to only and informed consent.
Data collection:
- Baseline characteristic data e.g. donor and recipient age, donor and recipient gender, HLA, PRA, anti-HBs titer, immunity against HBV status (both natural and vaccinated),immunosuppressive regimens were collected.
- The recipients were prospective followed up at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120.
- Clinical data including jaundice, hepatitis, graft rejection were collected
- Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT, eGFR were collected.
- Pathological data of allograft biopsy at month 12 and 24 were retrieved.
Outcomes:
- Primary outcome: hepatitis B transmission rate.
- Secondary outcome: graft survival, patient survival.
- Being tested
- HBsAg positive kidney allograft donor
- Keywords
- HBsAg(+) donor, HBsAg(-) donor, Anti-hepatitis B antibody, Kidney allograft
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBsAg positive kidney allograft donorBiological
| Study group | Role | What they receive |
|---|---|---|
| HBsAg negative kidney allograft donor | Not described | |
| HBsAg positive kidney allograft donor | HBsAg positive kidney allograft donor Receives: Biological: HBsAg positive kidney allograft donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B transmission rate
The hepatitis B transmission rate was determined at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 by using:
- Clinical data including jaundice, hepatitis, acute liver failure.
- Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT.
- Radiological data of liver ultrasonography.
Measured: January 2000 to December 2013
Secondary outcomes (1)
Graft survival rate
The graft survival rate was determined by Kaplan-Meyer survival analysis.
Measured: January 2000 to December 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2000
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HBsAg(+) Donor Kidney AllograftStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- 10 Years
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiwat Chancharoenthana, Chulalongkorn University
- Investigators
- Wiwat Chancharoenthana, MD, MSc, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044588
- Sponsor's protocol ID
- WWC-001
- Status last verified
- Jan 2014
- First submitted
- 20 Jan 2014
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chancharoenthana W, Townamchai N, Pongpirul K, Kittiskulnam P, Leelahavanichkul A, Avihingsanon Y, Suankratay C, Wattanatorn S, Kittikowit W, Praditpornsilpa K, Tungsanga K, Eiam-Ong S. The outcomes of kidney transplantation in hepatitis B surface antigen (HBsAg)-negative recipients receiving graft from HBsAg-positive donors: a retrospective, propensity score-matched study. Am J Transplant. 2014 Dec;14(12):2814-20. doi: 10.1111/ajt.12921. Epub 2014 Nov 13.
PubMed 25395260
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg
- ClinicalTrials.gov ID
- NCT02044588
- Acronym / sponsor ID
- WWC-001
- Keywords
- HBsAg(+) donor, HBsAg(-) donor, Anti-hepatitis B antibody, Kidney allograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2014 (estimated)
- First posted
- 24 Jan 2014 (estimated)
- 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.
To determine the safety of using kidney organ from hepatitis B surface antigen positive donor, the author conducted the single-center, prospective study of the use of these kidneys for recipients who have protective level of hepatitis B surface antibodies.
Detailed description
The kidney transplant registry was conducted in KCMH since the year of 2000 until the present.
The inclusion criterion was:
- All kidney allograft recipients who received at least one month after transplantation.
- All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.
The exclusion criterion was:
- The recipients with positive hepatitis C virus antibody.
- The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
- The recipients those lost to follow-up.
Study group:
- The recipients who received kidney allograft from the HBsAg(+) donor.
Control group:
- The recipients who received kidney allograft from the HBsAg(-) donor.
According to the Thai Red Cross National Organ Donation and our institute's policy, the HBsAg(+) kidney allografts were distributed to only and informed consent.
Data collection:
- Baseline characteristic data e.g. donor and recipient age, donor and recipient gender, HLA, PRA, anti-HBs titer, immunity against HBV status (both natural and vaccinated),immunosuppressive regimens were collected.
- The recipients were prospective followed up at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120.
- Clinical data including jaundice, hepatitis, graft rejection were collected
- Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT, eGFR were collected.
- Pathological data of allograft biopsy at month 12 and 24 were retrieved.
Outcomes:
- Primary outcome: hepatitis B transmission rate.
- Secondary outcome: graft survival, patient survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBsAg negative kidney allograft donor | – | – |
| HBsAg positive kidney allograft donor | – | Biological: HBsAg positive kidney allograft donorHBsAg positive kidney allograft donor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All kidney transplant recipients from January 1, 2000 until the present (upto year 2013) were prospective follow-up.
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 |
|---|---|---|
| HBsAg positive kidney allograft donor | Biological | HBsAg positive kidney allograft donor |
Primary outcome
Hepatitis B transmission rate
Time frame: January 2000 to December 2013
The hepatitis B transmission rate was determined at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 by using: * Clinical data including jaundice, hepatitis, acute liver failure. * Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT. * Radiological data of liver ultrasonography.
1 secondary outcome
Graft survival rate
Time frame: January 2000 to December 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Derived from this study: PubMed 25395260Chancharoenthana W, Townamchai N, Pongpirul K, Kittiskulnam P, Leelahavanichkul A, Avihingsanon Y, Suankratay C, Wattanatorn S, Kittikowit W, Praditpornsilpa K, Tungsanga K, Eiam-Ong S. The outcomes of kidney transplantation in hepatitis B surface antigen (HBsAg)-negative recipients receiving graft from HBsAg-positive donors: a retrospective, propensity score-matched study. Am J Transplant. 2014 Dec;14(12):2814-20. doi: 10.1111/ajt.12921. Epub 2014 Nov 13.
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.
Wiwat Chancharoenthana, MD, MSc contact
Wiwat Chancharoenthana, MD, MSc principal investigator
Chulalongkorn University
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 HBsAg(+) Donor Kidney Allograft and HBsAg(-) Donor Kidney Allograft, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jan 2014. 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 Thailand. 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 Wiwat Chancharoenthana, MD, MSc (wiwatmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis B transmission rate (time frame: January 2000 to December 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02044588, which also lists 1 linked publication.
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 24 Jan 2014.