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Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.

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.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02894554
Enrollment
19
Registered
2016-09-09
Start date
2014-07-31
Completion date
2015-07-31
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBsAg-positive Renal Allograft Recipients

Brief 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. 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.

Interventions

DRUGTelbivudine
DRUGLamivudine

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026