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.
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Poor renal function at baseline (eGFR<20)
- Known hypersensitivity or intolerance to any of the ingredients in Telbivudine
- Known history of Telbivudine resistance
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:lamivudine
HBsAg (+) patients received renal transplant and under lamivudine therapy.
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其他名称:
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有源比较器:telbivudine
HBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later.
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其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
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.
大体时间:48 weeks
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48 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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拉米夫定的临床试验
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Shanghai Public Health Clinical Center尚未招聘
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Thomas Benfield招聘中
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Merck Sharp & Dohme LLC完全的HIV-1 感染美国, 智利, 法国, 英国
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Merck Sharp & Dohme LLC完全的