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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
HBsAg-positive Renal Allograft Recipients Drug: Telbivudine Drug: Lamivudine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: lamivudine
HBsAg (+) patients received renal transplant and under lamivudine therapy.
Drug: Lamivudine
Other Name: Zeffix

Active Comparator: telbivudine
HBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later.
Drug: Telbivudine
Other Name: Sebivo




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02894554     History of Changes
Other Study ID Numbers: 201310070MINA
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Lamivudine
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents