HBsAg-positive Renal Allograft Recipients Clinical Trial
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | July 2015 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. Kidney transplant patients who are treated with Lamivudine over 6 months (Considering include post kidney transplantation > 6 months with stable calcineurin inhibitors level 2. Seropositive of HBsAg for 6 months 3. Willing and able to provide written informed consent Exclusion Criteria: 1. Hepatitis cirrhosis patients 2. Co-infection with hepatitis C virus or HIV 3. Pregnant or nursing 4. YMDD resistant at baseline 5. ABO incompatible renal transplantation 6. Cross match positive 7. Poor renal function at baseline (eGFR<20) 8. Known hypersensitivity or intolerance to any of the ingredients in Telbivudine 9. Known history of Telbivudine resistance |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 48 weeks | No |