Clinical trial NCT02447705: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Disorder Related to Transplantation
Virus Diseases
Injury Due to Exposure to External Cause
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Renal function measurement
timeFrame: every 2 months, up to 12 months
Secondary outcomes:
measure: hepatitis B recurrence
timeFrame: every 6 months, up to 12 months
Other outcomes:
Locations:
Study officials:
References:
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.