Replacement of Lamivudine by Telbivudine to Improve Renal Function
Primary Purpose
Disorder Related to Transplantation, Virus Diseases, Injury Due to Exposure to External Cause
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
telbivudine
Sponsored by
About this trial
This is an interventional treatment trial for Disorder Related to Transplantation
Eligibility Criteria
Inclusion Criteria:
- Sign inform consent
- Age is not less than 16 years old.
- Post liver transplantation patient for HBV-related indication.
- Chronic hepatitis B transplant patients who are treated by lamivudine for not less than 6 months.
- eGRF stage 2-4 patients (15<eGFR<90ml)
- Stable liver function, ALT not more than 2 folds of upper limit.
Exclusion Criteria:
- Acute rejection with increase CNI dose within a month.
- Pregnant or nursing.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Lamivudine group
Telbivudine group
Arm Description
continue Lamivudine
Telbivudine replaces Lamivudine
Outcomes
Primary Outcome Measures
Renal function measurement
Measure eGFR when the patients were enrolled, every 2 months and up to 12 months. The most important time point will be to compare eGRF at 6 month and 12 months after medication conversion to the beginning levels. Renal function is improved if eGRF is better after medication conversion.
Secondary Outcome Measures
hepatitis B recurrence
Measure hepatitis B surface antigen every 6 months. If HBs AG appears, hepatitis B recurrence is diagnosed.
Full Information
NCT ID
NCT02447705
First Posted
June 3, 2013
Last Updated
February 5, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02447705
Brief Title
Replacement of Lamivudine by Telbivudine to Improve Renal Function
Official Title
Replacement of Lamivudine by Telbivudine to Improve Renal Function for Post-transplant Hepatitis B Patients - a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular filtration rate. This study is to see whether renal function is improved when Lamivudine is replaced by telbivudine in liver transplantation patients.
Detailed Description
Liver transplantation is the only effective treatment for the patients with liver failure. Hepatitis B-related liver cirrhosis is the major indication to have liver transplantation in Taiwan. After liver transplantation, prophylaxis of hepatitis B recurrence will be performed by anti-hepatitis B immunoglobulin and anti-viral agents. Currently, lamivudine is the drug the investigators choose to prevent HBV recurrence for many years because it is safe for long-term use. However, nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Recently, the studies on chronic hepatitis B patients showed improvement of glomerular filtration rate for those receiving telbivudine treatment. In this study, the investigators will include our post-transplant HBV patients who have stable liver function, receive lamivudine for prophylaxis of recurrent hepatitis B, and have renal dysfunction in stage II-IV. The patients will be randomized to receive telbivudine or lamivudine continuously at 1:1 ratio. Renal function will be examined at 6 months interval to determine whether renal function is improved. The achievement will determine whether telbivudine is better than lamivudine for the HBV patients with renal dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder Related to Transplantation, Virus Diseases, Injury Due to Exposure to External Cause
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lamivudine group
Arm Type
No Intervention
Arm Description
continue Lamivudine
Arm Title
Telbivudine group
Arm Type
Experimental
Arm Description
Telbivudine replaces Lamivudine
Intervention Type
Drug
Intervention Name(s)
telbivudine
Other Intervention Name(s)
sobivo
Intervention Description
telbivudine replace Lamivudine
Primary Outcome Measure Information:
Title
Renal function measurement
Description
Measure eGFR when the patients were enrolled, every 2 months and up to 12 months. The most important time point will be to compare eGRF at 6 month and 12 months after medication conversion to the beginning levels. Renal function is improved if eGRF is better after medication conversion.
Time Frame
every 2 months, up to 12 months
Secondary Outcome Measure Information:
Title
hepatitis B recurrence
Description
Measure hepatitis B surface antigen every 6 months. If HBs AG appears, hepatitis B recurrence is diagnosed.
Time Frame
every 6 months, up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Sign inform consent
Age is not less than 16 years old.
Post liver transplantation patient for HBV-related indication.
Chronic hepatitis B transplant patients who are treated by lamivudine for not less than 6 months.
eGRF stage 2-4 patients (15<eGFR<90ml)
Stable liver function, ALT not more than 2 folds of upper limit.
Exclusion Criteria:
Acute rejection with increase CNI dose within a month.
Pregnant or nursing.
12. IPD Sharing Statement
Citations:
PubMed Identifier
28884132
Citation
Lee WC, Wu TH, Wang YC, Cheng CH, Lee CF, Wu TJ, Chou HS, Chan KM, Lee CS. Renal Function Improvement by Telbivudine in Liver Transplant Recipients with Chronic Kidney Disease. Biomed Res Int. 2017;2017:9324310. doi: 10.1155/2017/9324310. Epub 2017 Aug 13.
Results Reference
derived
Learn more about this trial
Replacement of Lamivudine by Telbivudine to Improve Renal Function
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