Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.
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|ClinicalTrials.gov Identifier: NCT02894554|
Recruitment Status : Terminated (clinical myalgia)
First Posted : September 9, 2016
Last Update Posted : September 9, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|HBsAg-positive Renal Allograft Recipients||Drug: Telbivudine Drug: Lamivudine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||July 2015|
Placebo Comparator: lamivudine
HBsAg (+) patients received renal transplant and under lamivudine therapy.
Other Name: Zeffix
Active Comparator: telbivudine
HBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later.
Other Name: Sebivo
- 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 ]