Replacement of Lamivudine by Telbivudine to Improve Renal Function

Phase 2

Completed

• Conditions: Virus Diseases; Disorder Related to Transplantation; Injury Due to Exposure to External Cause
• Interventions: Drug: telbivudine

• Registration Number: NCT02447705
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Primary Completion: 2016-12-31
• Study Completion: 2017-01-31
• Last Update Submitted: 2017-02-05
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Sign inform consent
2. Age is not less than 16 years old.
3. Post liver transplantation patient for HBV-related indication.
4. Chronic hepatitis B transplant patients who are treated by lamivudine for not less than 6 months.
5. eGRF stage 2-4 patients (15<eGFR<90ml)
6. Stable liver function, ALT not more than 2 folds of upper limit.

Exclusion Criteria

1. Acute rejection with increase CNI dose within a month.
2. Pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telbivudine group	telbivudine	Telbivudine replaces Lamivudine

Primary Outcome Measures

Name	Time	Method
Renal function measurement	every 2 months, up to 12 months	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

Name	Time	Method
hepatitis B recurrence	every 6 months, up to 12 months	Measure hepatitis B surface antigen every 6 months. If HBs AG appears, hepatitis B recurrence is diagnosed.