HBsAg-positive Renal Allograft RecipientsPhase 4NCT02894554
Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.
A Phase 4 study testing Telbivudine and Lamivudine in people with HBsAg-positive Renal Allograft Recipients, run by National Taiwan University Hospital.
Trial summary
The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported from 3% to 20.9%. And patient survival and graft survival rates following renal transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HBsAg-positive Renal Allograft Recipients
- What is being tested?
- Telbivudine and Lamivudine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant patients who are treated with Lamivudine over 6 months (Considering include post kidney transplantation > 6 months with stable calcineurin inhibitors level
- Seropositive of HBsAg for 6 months
- Willing and able to provide written informed consent
Who cannot join
- Hepatitis cirrhosis patients
- Co-infection with hepatitis C virus or HIV
- Pregnant or nursing
- YMDD resistant at baseline
- ABO incompatible renal transplantation
- Cross match positive
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- Poor renal function at baseline (eGFR<20)
- Known hypersensitivity or intolerance to any of the ingredients in Telbivudine
- Known history of Telbivudine resistance
About this study
Official title: A Single-Center, Open-Label Study to Evaluate the Renal Function Improvement in Lamivudine Long Term Used HBsAg Positive Kidney Transplantation Patients After Switch to Telbivudine Treatment.
The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported from 3% to 20.9%. And patient survival and graft survival rates following renal transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients. Due to viral replication in asymptomatic HBV carriers induced by post-transplant immunosuppression, liver-related complications, such as liver failure and bleeding, account for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.
Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal allograft recipients has significantly improved patient survival rates during short-term follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine treatment.
However, limited results were known about the renal function affected by oral anti-HBV drugs when patients received kidney transplantation. Therefore, we would like to conduct this study to evaluate the renal function of Lamivudine long term used HBsAg positive patients received kidney transplantation after switch to Telbivudine treatment. The clinical and virological outcomes will provide valuable insights of clinical practice.
- Being tested
- Telbivudine, Lamivudine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelbivudineDrug
Also called Sebivo
LamivudineDrug
Also called Zeffix
| Study group | Role | What they receive |
|---|---|---|
| lamivudine | Placebo comparator | HBsAg (+) patients received renal transplant and under lamivudine therapy. Receives: Drug: Lamivudine |
| telbivudine | Active comparator | HBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later. Receives: Drug: Telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the renal function in HBsAg positive kidney transplant patients in Telbivudine and Lamivudine treatment groups by eGFR at 48 Weeks after treatment using MDRD formula.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionJul 2015
Why it stopped: clinical myalgia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBsAg-positive Renal Allograft RecipientsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894554
- Sponsor's protocol ID
- 201310070MINA
- Status last verified
- Sep 2016
- First submitted
- 7 Jul 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study to Evaluate the Renal Function Improvement in Lamivudine Long Term Used HBsAg Positive Kidney Transplantation Patients After Switch to Telbivudine Treatment.
- ClinicalTrials.gov ID
- NCT02894554
- Acronym / sponsor ID
- 201310070MINA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: clinical myalgia
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Sep 2016 (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.
The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported from 3% to 20.9%. And patient survival and graft survival rates following renal transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients. Due to viral replication in asymptomatic HBV carriers induced by post-transplant immunosuppression, liver-related complications, such as liver failure and bleeding, account for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.
Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal allograft recipients has significantly improved patient survival rates during short-term follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine treatment.
However, limited results were known about the renal function affected by oral anti-HBV drugs when patients received kidney transplantation. Therefore, we would like to conduct this study to evaluate the renal function of Lamivudine long term used HBsAg positive patients received kidney transplantation after switch to Telbivudine treatment. The clinical and virological outcomes will provide valuable insights of clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lamivudine | Placebo comparator | Drug: LamivudineHBsAg (+) patients received renal transplant and under lamivudine therapy. |
| telbivudine | Active comparator | Drug: TelbivudineHBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplant patients who are treated with Lamivudine over 6 months (Considering include post kidney transplantation > 6 months with stable calcineurin inhibitors level
- Seropositive of HBsAg for 6 months
- Willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Hepatitis cirrhosis patients
- Co-infection with hepatitis C virus or HIV
- Pregnant or nursing
- YMDD resistant at baseline
- ABO incompatible renal transplantation
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 |
|---|---|---|
| TelbivudineAlso: Sebivo | Drug | telbivudine |
| LamivudineAlso: Zeffix | Drug | lamivudine |
Primary outcome
To evaluate the renal function in HBsAg positive kidney transplant patients in Telbivudine and Lamivudine treatment groups by eGFR at 48 Weeks after treatment using MDRD formula.
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: clinical myalgia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telbivudine and Lamivudine in people with HBsAg-positive Renal Allograft Recipients, run by National Taiwan University Hospital.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: clinical myalgia). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the renal function in HBsAg positive kidney transplant patients in Telbivudine and Lamivudine treatment groups by eGFR at 48 Weeks after treatment using MDRD formula. (time frame: 48 weeks). 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 9 Sep 2016.