Replacement of Lamivudine by Telbivudine to Improve Renal Function
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2013
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2017
CompletedFebruary 7, 2017
March 1, 2013
3.6 years
June 3, 2013
February 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
every 2 months, up to 12 months
Secondary Outcomes (1)
hepatitis B recurrence
every 6 months, up to 12 months
Study Arms (2)
Lamivudine group
NO INTERVENTIONcontinue Lamivudine
Telbivudine group
EXPERIMENTALTelbivudine replaces Lamivudine
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Acute rejection with increase CNI dose within a month.
- Pregnant or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28884132DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2013
First Posted
May 19, 2015
Study Start
June 1, 2013
Primary Completion
December 31, 2016
Study Completion
January 31, 2017
Last Updated
February 7, 2017
Record last verified: 2013-03